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CompletedNCT04079790Updated Sep 4, 2020Results posted

Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects

A Phase 1 interventional study of Gepotidacin and Placebo in Infections, Bacterial, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 12 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
12 Years to 64 Years
Sex
All
01

Study summary

This is double-blind, randomized, sequential, two part study. Part 1 is a 3 periods, fixed-sequence study and will be conducted to evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adult subjects. Part 2 is a 2 periods, fixed-sequence study and will evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adolescent subjects. The primary purpose of Part 1 is to evaluate the pharmacokinetics of a single 1500 milligram (mg) dose and two 3000 mg doses of gepotidacin given 6 and 12 hours apart in adult subjects; Part 2 is to evaluate the pharmacokinetics of a single 1500 mg dose and two 3000 mg doses of gepotidacin given at a dosing interval (to be determined based on the pharmacokinetic and safety results from Part 1) in adolescent subjects. The duration of Part A will be approximately 47 days and 52 days for Part 2.

02

Conditions studied

  • Infections, Bacterial

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Keywords

  • GSK2140944
  • Gepotidacin
  • Pharmacokinetics
  • Healthy Adult
  • Healthy adolescent
03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's enrollment of 34 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects in Part 1 must be >=18 to \<=64 years of age inclusive, at the time of signing the informed consent.
  • Subjects in Part 2 must be >=12 to \<18 years of age inclusive, at the time of signing the informed consent/assent.
  • Subjects who are healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECG results \<450 millisecond (msec). A subject with clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator feels and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Body weight >=40 kilogram (kg) and body mass index (BMI) within the range 18.5 - 32.0 kg per square meter (inclusive).
  • Male and/or female.
  • Female subjects: A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) Is not a woman of childbearing potential (WOCBP), or b) Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of \<1% for at least 30 days prior to dosing until completion of the follow-up visit. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a highly sensitive negative pregnancy test before the first dose of study intervention.
  • Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form/assent and protocol.

Exclusion criteria

Exclusion Criteria

  • Clinically significant abnormality in the past medical history or at the screening physical examination that in the investigator's opinion may place the subject at risk or interfere with outcome variables of the study. This includes, but is not limited to, history or current cardiac, hepatic, renal, neurologic, gastrointestinal (GI), respiratory, hematologic, or immunologic disease.
  • Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention, or any other condition that may place the subject at risk, in the opinion of the investigator.
  • Female subject has a positive pregnancy test result or is lactating at screening or upon admission to the clinic.
  • Use of any systemic antibiotic within 30 days of screening.
  • Within 2 months before screening, either a confirmed history of Clostridium difficile diarrhea infection or a past positive of Clostridium difficile toxin test.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • History of drug and/or alcohol abuse within 6 months before screening, as determined by the investigator, or has a positive drug screen at screening or upon admission to the clinic.
  • History of sensitivity to any of the study drug, components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline medical monitor contraindicates their participation.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinic uses heparin to maintain intravenous cannula patency).
  • Subject must abstain from taking prescription or non-prescription drugs (except for hormonal contraceptives and/or acetaminophen), vitamins, and dietary or herbal supplements, within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study. Any exceptions will be discussed with the sponsor or medical monitor on a case-by-case basis and the reasons will be documented.
  • Previous exposure to gepotidacin within 12 months prior to starting study intervention.
  • Subject has participated in a clinical trial and has received an investigational product prior to gepotidacin administration within 30 days, 5 half-lives, or twice the duration of the biological effect of investigational product (whichever is longer).
  • Presence of hepatitis B surface antigen or positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
  • ALT >1.5 * upper limit of normal (ULN).
  • Bilirubin >1.5 * ULN (isolated bilirubin >1.5 * ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
  • History of any kidney disease or current or chronic history of impaired renal function as indicated by an estimated creatinine clearance \<60 milliliter per minute (mL/min).
  • A positive test for human immunodeficiency virus antibody.
  • History of regular alcohol consumption within 6 months of screening defined as an average weekly intake of >21 units (or an average daily intake of >3 units) for males or an average weekly intake of >14 units (or an average daily intake >2 units) for females. One unit is equivalent to 270 mL of full strength beer, 470 mL of light beer, 30 mL of spirits, or 100 mL of wine.
  • Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months before screening.
  • Clinically significant abnormal findings in serum chemistry, hematology, or urinalysis results obtained at screening or Day -1.
  • Baseline corrected QT interval using the Fridericia formula (QTcF) of >450 msec.
  • Subject has donated blood in excess of 500 mL within 12 weeks prior to dosing or participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
  • Subject is unable to comply with all study procedures, in the opinion of the investigator.
  • Subject should not participate in the study, in the opinion of the investigator or sponsor.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Subjects receiving Gepotidacin in Part 1

    Healthy adult subjects will receive a single oral dose of gepotidacin 1500 mg (2 X 750 mg, treatment A), tablets, on Day 1 of Period 1; two oral doses of gepotidacin 3000 mg (4 x 750 mg, Treatment C), tablets, at 0 and 12 hours on Day 5 of Period 2; and two oral doses of gepotidacin 3000 mg (4 x 750 mg, treatment E), tablets, at 0 and 6 hours on Day 9 of Period 3.

    Drug: Gepotidacin

  • Placebo comparator
    Subjects receiving Placebo in Part 1

    Healthy adult subjects will receive a single oral dose of matching placebo (treatment B), tablets, on Day 1 of Period 1; two oral doses of matching placebo (treatment D), tablets, at 0 and 12 hours on Day 5 of Period 2; and two oral doses of matching placebo (treatment F), tablets, at 0 and 6 hours on Day 9 of Period 3.

    Drug: Placebo

  • Experimental
    Subjects receiving Gepotidacin in Part 2

    Healthy adolescent subjects will receive a single oral dose of gepotidacin 1500 mg (2 x 750 mg, treatment A), tablets, on Day 1 of Period 1; and two oral doses of gepotidacin 3000 mg (4 x 750 mg, treatment G), tablets, at 0 and 6 hours on Day 1 of Period 2.

    Drug: Gepotidacin

  • Placebo comparator
    Subjects receiving Placebo in Part 2

    Healthy adolescent subjects will receive a single oral dose of matching placebo (treatment B), tablets on Day 1 of Period 1; and two oral doses of matching placebo (treatment H), tablets at 0 and 6 hours on Day 1 of Period 2.

    Drug: Placebo

Interventions

  • DrugGepotidacin

    Tablets containing gepotidacin mesylate with a unit dose of 750 mg will be administered orally with 240 milliliter (mL) of water.

  • DrugPlacebo

    Tablets containing unit dose of placebo matching of gepotidacin will be administered orally with 240 mL of water.

06

What researchers measure

Primary outcomes

  1. Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  2. Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  3. Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose

  4. Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 48 Hours Post-dose (AUC[0-48]) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  5. Part 1- Period 1: Maximum Observed Concentration (Cmax) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  6. Part 1- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose

  7. Part 1- Period 3: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose

  8. Part 1- Period 2: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time Tau (Tau=12) (AUC[0-tau]) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose

  9. Part 1- Period 3: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dose

  10. Part 1- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 and 24 hours post-dose

  11. Part 1- Period 3: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dose

  12. Part 1- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36 and 48 hours post-dose

  13. Part 1- Period 3: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose

  14. Part 1- Period 2: Accumulation Ratio for Cmax (RoCmax) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose

  15. Part 1- Period 2: Accumulation Ratio for AUC (RoAUC) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose

  16. Part 1- Period 3: RoCmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose

  17. Part 1- Period 3: RoAUC Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose

  18. Part 1- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose

  19. Part 1- Period 3: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose

  20. Part 2- Period 1: AUC(0-t) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  21. Part 2- Period 1: AUC(0-infinity) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  22. Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose

  23. Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  24. Part 2- Period 1: Cmax After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  25. Part 2- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose

  26. Part 2- Period 2: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dose

  27. Part 2- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dose

  28. Part 2- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose

  29. Part 2- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose

  30. Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs is presented.

    Time frame: Up to Day 19

  31. Part 2: Number of Participants With Non-serious AEs and SAEs

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs are presented.

    Time frame: Up to Day 21

  32. Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher

    Blood samples were collected for the analysis of following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented.

    Time frame: Up to Day 19

  33. Part 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher

    Blood samples were collected for the analysis of following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented.

    Time frame: Up to Day 21

  34. Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher

    Blood samples were collected for the analysis of following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose (fasting), potassium, sodium, magnesium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented

    Time frame: Up to Day 19

  35. Part 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher

    Blood samples were collected for the analysis of following clinical chemistry parameters: BUN, creatinine, glucose (fasting), potassium, sodium, magnesium, AST, ALT, alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented

    Time frame: Up to Day 21

  36. Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher

    Urine samples were collected for the analysis of urine parameters including specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented

    Time frame: Up to Day 19

  37. Part 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher

    Urine samples were collected for the analysis of urine parameters including specific gravity, pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented

    Time frame: Up to Day 21

  38. Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance

    SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 millimeters of mercury \[mmHg\]) and DBP (lower: \<45 and upper: \>100 mmHg).

    Time frame: Up to Day 19

  39. Part 2: Number of Participants With SBP and DBP of Potential Clinical Importance

    SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 mmHg) and DBP (lower: \<45 and upper: \>100 mmHg).

    Time frame: Up to Day 21

  40. Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance

    Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute).

    Time frame: Up to Day 19

  41. Part 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance

    Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute).

    Time frame: Up to Day 21

  42. Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings

    A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

    Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3.

  43. Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings

    A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

    Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3

  44. Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings

    A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

    Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3

  45. Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings

    A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

    Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3

  46. Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings

    A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

    Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3

Secondary outcomes

  1. Part 1- Period 1: Total Unchanged Drug (Ae Total) After Single Dose Administration of Gepotidacin 1500 mg

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose

  2. Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg

    Urine samples were collected at the specified intervals for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

    Time frame: 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose

  3. Part 1- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose.

  4. Part 1- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)

    Urine samples were be collected at indicated time points for pharmacokinetic analysis of gepotidacin.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose

  5. Part 1- Period 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) After Single Dose Administration of Gepotidacin 1500 mg

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100 percent (%).

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose

  6. Part 1- Period 1: Renal Clearance of Drug (CLr) After Single Dose Administration of Gepotidacin 1500 mg

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose

  7. Part 1- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

    Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose

  8. Part 1- Period 3: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

    Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose

  9. Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals

    Time frame: 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose

  10. Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

    Time frame: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18 -24, 24-36, 36-48 and 48-60 hours post-dose

  11. Part 1- Period 2: AUC(0-tau) (Tau=12 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8 and 8-12 hours post-dose

  12. Part 1- Period 3: AUC(0-tau) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin

    Time frame: Pre-dose, 0-2, 2-4 and 4-6 hours post-dose

  13. Part 1- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20 and 20-24 hours post dose

  14. Part 1- Period 3: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dose

  15. Part 1- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36 and 36-48 hours post-dose

  16. Part 1- Period 3: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose

  17. Part 1- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose

  18. Part 1- Period 3: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose

  19. Part 1- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose

  20. Part 1- Period 3: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose

  21. Part 2- Period 1: Ae Total After Single Dose Administration of Gepotidacin 1500 mg

    Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose

  22. Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

    Time frame: 0-2, 2-4, 4-6, 6-8, 8-12, 12-24,24-36 and 36-48 hours post-dose

  23. Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose.

  24. Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose

  25. Part 2- Period 1: fe% After Single Dose Administration of Gepotidacin 1500 mg

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose

  26. Part 2- Period 1: CLr After Single Dose Administration of Gepotidacin 1500 mg

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose

  27. Part 2- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

    Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose

  28. Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

    Time frame: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose

  29. Part 2- Period 2: AUC(0-tau) (Tau=6 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)

    Urine samples will be collected at indicated time points for pharmacokinetic analysis of gepotidacin

    Time frame: Pre-dose, 0-2, 2-4, 4-6 hours post-dose

  30. Part 2- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dose

  31. Part 2- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)

    Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose.

  32. Part 2- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose

  33. Part 2- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

    Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).

    Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose

  34. Part 1- Period 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  35. Part 1- Period 1: Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  36. Part 1- Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  37. Part 1- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose

  38. Part 1- Period 3: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose

  39. Part 1- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose

  40. Part 1- Period 3: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose

  41. Part 1- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose

  42. Part 1- Period 3: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose

  43. Part 2- Period 1: Tmax After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  44. Part 2- Period 1: Tlag After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  45. Part 2- Period 1: t1/2 After Single Dose Administration of Gepotidacin 1500 mg

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

  46. Part 2- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose

  47. Part 2- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose

  48. Part 2- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

    Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose

07

Results

Posted Sep 4, 2020

Participant flow

This was a two-part, double-blind, randomized, sequential study to evaluate pharmacokinetics of Gepotidacin in healthy adult and adolescent participants. The study was conducted at a single center in the United States.

Part 1, Period 1(Day 1 to Day 4)
Participant flow — Part 1, Period 1(Day 1 to Day 4)
MilestoneGepotidacin (A/C/E)Placebo (B/D/F)Gepotidacin (A/G)Placebo (B/H)
Started14200
Completed13200
Not completed1000
Withdrew: Withdrawal by subject1000
Part 1, Period 2 (Day 5 to Day 8)
Participant flow — Part 1, Period 2 (Day 5 to Day 8)
MilestoneGepotidacin (A/C/E)Placebo (B/D/F)Gepotidacin (A/G)Placebo (B/H)
Started13200
Completed13200
Not completed0000
Part 1, Period 3 (Day 9 to Day 11)
Participant flow — Part 1, Period 3 (Day 9 to Day 11)
MilestoneGepotidacin (A/C/E)Placebo (B/D/F)Gepotidacin (A/G)Placebo (B/H)
Started13200
Completed13200
Not completed0000
Part 2, Period 1 (Day 1 to Day 3)
Participant flow — Part 2, Period 1 (Day 1 to Day 3)
MilestoneGepotidacin (A/C/E)Placebo (B/D/F)Gepotidacin (A/G)Placebo (B/H)
Started00153
Completed00123
Not completed0030
Withdrew: Withdrawal by subject0010
Withdrew: Unable to swallow0020
Part 2, Period 2 (Day 1 to Day 3)
Participant flow — Part 2, Period 2 (Day 1 to Day 3)
MilestoneGepotidacin (A/C/E)Placebo (B/D/F)Gepotidacin (A/G)Placebo (B/H)
Started00123
Completed00123
Not completed0000

Outcome measures

PrimaryPart 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of Gepotidacin 1500 mg
Hours*micrograms per milliliterPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of Gepotidacin 1500 mg19.69 ± 17.6
PrimaryPart 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) After Single Dose Administration of Gepotidacin 1500 mg
Hours*micrograms per milliliterPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) After Single Dose Administration of Gepotidacin 1500 mg20.15 ± 16.8
PrimaryPart 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) After Single Dose Administration of Gepotidacin 1500 mg
Hours*micrograms per milliliterPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) After Single Dose Administration of Gepotidacin 1500 mg18.66 ± 19.5
PrimaryPart 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 48 Hours Post-dose (AUC[0-48]) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 48 Hours Post-dose (AUC[0-48]) After Single Dose Administration of Gepotidacin 1500 mg
Hours*micrograms per milliliterPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 48 Hours Post-dose (AUC[0-48]) After Single Dose Administration of Gepotidacin 1500 mg19.72 ± 17.6
PrimaryPart 1- Period 1: Maximum Observed Concentration (Cmax) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Micrograms per milliliter
Part 1- Period 1: Maximum Observed Concentration (Cmax) After Single Dose Administration of Gepotidacin 1500 mg
Micrograms per milliliterPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Maximum Observed Concentration (Cmax) After Single Dose Administration of Gepotidacin 1500 mg3.574 ± 38.1
PrimaryPart 1- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval91.21 ± 22.6
PrimaryPart 1- Period 3: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 3: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval87.09 ± 26.3
PrimaryPart 1- Period 2: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time Tau (Tau=12) (AUC[0-tau]) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 2: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time Tau (Tau=12) (AUC[0-tau]) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 12 Hour Interval
Dose 138.15 ± 24.3
Dose 244.41 ± 22.8
PrimaryPart 1- Period 3: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 3: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 6 Hour Interval
Dose 124.09 ± 33.6
Dose 240.13 ± 29.5
PrimaryPart 1- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 and 24 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval83.45 ± 22.7
PrimaryPart 1- Period 3: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 3: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval82.43 ± 27.3
PrimaryPart 1- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval90.53 ± 22.7
PrimaryPart 1- Period 3: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 1- Period 3: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval86.49 ± 26.4
PrimaryPart 1- Period 2: Accumulation Ratio for Cmax (RoCmax) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Ratio
Part 1- Period 2: Accumulation Ratio for Cmax (RoCmax) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
RatioPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: Accumulation Ratio for Cmax (RoCmax) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval1.109 ± 30.6
PrimaryPart 1- Period 2: Accumulation Ratio for AUC (RoAUC) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Ratio
Part 1- Period 2: Accumulation Ratio for AUC (RoAUC) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
RatioPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: Accumulation Ratio for AUC (RoAUC) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval1.164 ± 12.7
PrimaryPart 1- Period 3: RoCmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Ratio
Part 1- Period 3: RoCmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
RatioPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: RoCmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval1.544 ± 25.9
PrimaryPart 1- Period 3: RoAUC Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Ratio
Part 1- Period 3: RoAUC Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
RatioPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: RoAUC Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval1.666 ± 25.9
PrimaryPart 1- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Micrograms per milliliter
Part 1- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Micrograms per milliliterPart 1: Gepotidacin 3000 mg 12 Hour Interval
Dose 19.937 ± 24.2
Dose 211.02 ± 28.1
PrimaryPart 1- Period 3: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Micrograms per milliliter
Part 1- Period 3: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Micrograms per milliliterPart1: Gepotidacin 3000 mg 6 Hour Interval
Dose 18.423 ± 41.8
Dose 213.01 ± 28.6
PrimaryPart 2- Period 1: AUC(0-t) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 2- Period 1: AUC(0-t) After Single Dose Administration of Gepotidacin 1500 mg
Hours*micrograms per milliliterPart 2: Gepotidacin 1500 mg
Part 2- Period 1: AUC(0-t) After Single Dose Administration of Gepotidacin 1500 mg23.27 ± 21.6
PrimaryPart 2- Period 1: AUC(0-infinity) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 2- Period 1: AUC(0-infinity) After Single Dose Administration of Gepotidacin 1500 mg
Hours*micrograms per milliliterPart 2: Gepotidacin 1500 mg
Part 2- Period 1: AUC(0-infinity) After Single Dose Administration of Gepotidacin 1500 mg23.79 ± 20.9
PrimaryPart 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg
Hours*micrograms per milliliterPart 2: Gepotidacin 1500 mg
Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg22.06 ± 22.6
PrimaryPart 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg
Hours*micrograms per milliliterPart 2: Gepotidacin 1500 mg
Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg23.27 ± 21.6
PrimaryPart 2- Period 1: Cmax After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Micrograms per milliliter
Part 2- Period 1: Cmax After Single Dose Administration of Gepotidacin 1500 mg
Micrograms per milliliterPart 2: Gepotidacin 1500 mg
Part 2- Period 1: Cmax After Single Dose Administration of Gepotidacin 1500 mg4.523 ± 29.5
PrimaryPart 2- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 2- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Hours*micrograms per milliliterPart 2-Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval115.6 ± 23.8
PrimaryPart 2- Period 2: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 2- Period 2: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Hours*micrograms per milliliterPart 2: Gepotidacin 3000 mg 6 Hour Interval
Dose 132.37 ± 22.0
Dose 253.85 ± 26.7
PrimaryPart 2- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 2- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Hours*micrograms per milliliterPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval111.4 ± 23.8
PrimaryPart 2- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours*micrograms per milliliter
Part 2- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Hours*micrograms per milliliterPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval115.6 ± 23.8
PrimaryPart 2- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Micrograms per milliliter
Part 2- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Micrograms per milliliterPart 2: Gepotidacin 3000 mg 6 Hour Interval
Dose 110.86 ± 26.8
Dose 214.29 ± 29.5
PrimaryPart 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs is presented.

Time frame:
Up to Day 19
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
ParticipantsPart 1: PlaceboPart 1: Gepotidacin 1500 mgPart 1: Gepotidacin 3000 mg 12 Hour IntervalPart 1: Gepotidacin 3000 mg 6 Hour Interval
Common non-serious AEs01109
SAEs0000
PrimaryPart 2: Number of Participants With Non-serious AEs and SAEs

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs are presented.

Time frame:
Up to Day 21
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Non-serious AEs and SAEs
ParticipantsPart 2: PlaceboPart 2: Gepotidacin 1500 mgPart 2: Gepotidacin 3000 mg 6 Hour Interval
Common non-serious AEs2912
SAEs000
PrimaryPart 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher

Blood samples were collected for the analysis of following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented.

Time frame:
Up to Day 19
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher
ParticipantsPart 1: PlaceboPart 1: Gepotidacin 1500 mgPart 1: Gepotidacin 3000 mg 12 Hour IntervalPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher0000
PrimaryPart 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher

Blood samples were collected for the analysis of following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented.

Time frame:
Up to Day 21
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher
ParticipantsPart 2: PlaceboPart 2: Gepotidacin 1500 mgPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher000
PrimaryPart 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher

Blood samples were collected for the analysis of following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose (fasting), potassium, sodium, magnesium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented

Time frame:
Up to Day 19
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher
ParticipantsPart 1: PlaceboPart 1: Gepotidacin 1500 mgPart 1: Gepotidacin 3000 mg 12 Hour IntervalPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher0000
PrimaryPart 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher

Blood samples were collected for the analysis of following clinical chemistry parameters: BUN, creatinine, glucose (fasting), potassium, sodium, magnesium, AST, ALT, alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented

Time frame:
Up to Day 21
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher
ParticipantsPart 2: PlaceboPart 2: Gepotidacin 1500 mgPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher113
PrimaryPart 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher

Urine samples were collected for the analysis of urine parameters including specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented

Time frame:
Up to Day 19
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher
ParticipantsPart 1: PlaceboPart 1: Gepotidacin 1500 mgPart 1: Gepotidacin 3000 mg 12 Hour IntervalPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher0000
PrimaryPart 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher

Urine samples were collected for the analysis of urine parameters including specific gravity, pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented

Time frame:
Up to Day 21
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher
ParticipantsPart 2: PlaceboPart 2: Gepotidacin 1500 mgPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher000
PrimaryPart 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance

SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 millimeters of mercury \[mmHg\]) and DBP (lower: \<45 and upper: \>100 mmHg).

Time frame:
Up to Day 19
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance
ParticipantsPart 1: PlaceboPart 1: Gepotidacin 1500 mgPart 1: Gepotidacin 3000 mg 12 Hour IntervalPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance0011
PrimaryPart 2: Number of Participants With SBP and DBP of Potential Clinical Importance

SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 mmHg) and DBP (lower: \<45 and upper: \>100 mmHg).

Time frame:
Up to Day 21
Reported as:
Count of participants · Participants
Part 2: Number of Participants With SBP and DBP of Potential Clinical Importance
ParticipantsPart 2: PlaceboPart 2: Gepotidacin 1500 mgPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2: Number of Participants With SBP and DBP of Potential Clinical Importance000
PrimaryPart 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance

Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute).

Time frame:
Up to Day 19
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance
ParticipantsPart 1: PlaceboPart 1: Gepotidacin 1500 mgPart 1: Gepotidacin 3000 mg 12 Hour IntervalPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance0001
PrimaryPart 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance

Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute).

Time frame:
Up to Day 21
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance
ParticipantsPart 2: PlaceboPart 2: Gepotidacin 1500 mgPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance010
PrimaryPart 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings

A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame:
Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3.
Reported as:
Count of participants · Participants
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
ParticipantsPart 1: PlaceboPart 1: Gepotidacin 1500 mg
Abnormal, NCS, Day 1- predose, n= 2, 1418
Abnormal, CS, Day 1- predose, n= 2, 1400
Abnormal, NCS, Day 1- predose 2, n= 2, 14111
Abnormal, CS, Day 1-predose 2, n= 2, 1400
Abnormal, NCS, Day 1- predose 3, n= 2, 14112
Abnormal, CS, Day 1- predose 3, n= 2, 1400
Abnormal, NCS, Day 1- 0.5 hours, n= 2, 1407
Abnormal, CS, Day 1- 0.5 hours, n= 2, 1400
Abnormal, NCS, Day 1- 1 hour, n= 2, 1407
Abnormal, CS, Day 1- 1 hour, n= 2, 1400
Abnormal, NCS, Day 1- 1.5 hours, n= 2, 1409
Abnormal, CS, Day 1- 1.5 hours, n= 2, 1400
Abnormal, NCS, Day 1- 2 hours, n= 2, 1409
Abnormal, CS, Day 1- 2 hours, n= 2, 1400
Abnormal, NCS, Day 1- 2.5 hours, n= 2, 14110
Abnormal, CS, Day 1- 2.5 hours, n= 2, 1400
Abnormal, NCS, Day 1- 3 hours, n= 2, 1408
Abnormal, CS, Day 1- 3 hours, n= 2, 1400
Abnormal, NCS, Day 1- 4 hours, n= 2, 14111
Abnormal, CS, Day 1- 4 hours, n= 2, 1400
Abnormal, NCS, Day 1- 6 hours, n= 2, 1419
Abnormal, CS, Day 1- 6 hours, n= 2, 1400
Abnormal, NCS, Day 1- 8 hours, n= 2, 1419
Abnormal, CS, Day 1- 8 hours, n= 2, 1400
Abnormal, NCS, Day 1- 12 hours, n= 2, 1409
Abnormal, CS, Day 1- 12 hours, n= 2, 1400
Abnormal, NCS, Day 2- 24 hours, n= 2, 14110
Abnormal, CS, Day 2- 24 hours, n= 2, 1400
Abnormal, NCS, Day 2- 36 hours, n= 2, 1305
Abnormal, CS, Day 2- 36 hours, n= 2, 1300
Abnormal, NCS, Day 3- 48 hours, n= 2, 13111
Abnormal, CS, Day 3- 48 hours, n= 2, 1300
PrimaryPart 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings

A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame:
Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3
Reported as:
Count of participants · Participants
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
ParticipantsPart 1: PlaceboPart 1: Gepotidacin 3000 mg 12 Hour Interval
Abnormal, NCS, Day 1- predose28
Abnormal, CS, Day 1- predose00
Abnormal, NCS, Day 1- predose 228
Abnormal, CS, Day 1-predose 200
Abnormal, NCS, Day 1- predose 319
Abnormal, CS, Day 1- predose 300
Abnormal, NCS, Day 1- 0.5 hours19
Abnormal, CS, Day 1- 0.5 hours00
Abnormal, NCS, Day 1- 1 hour110
Abnormal, CS, Day 1- 1 hour00
Abnormal, NCS, Day 1- 1.5 hours18
Abnormal, CS, Day 1- 1.5 hours00
Abnormal, NCS, Day 1- 2 hours19
Abnormal, CS, Day 1- 2 hours00
Abnormal, NCS, Day 1- 2.5 hours17
Abnormal, CS, Day 1- 2.5 hours00
Abnormal, NCS, Day 1- 3 hours19
Abnormal, CS, Day 1- 3 hours00
Abnormal, NCS, Day 1- 4 hours27
Abnormal, CS, Day 1- 4 hours00
Abnormal, NCS, Day 1- 6 hours19
Abnormal, CS, Day 1- 6 hours00
Abnormal, NCS, Day 1- 8 hours19
Abnormal, CS, Day 1- 8 hours00
Abnormal, NCS, Day 1- 12 hours18
Abnormal, CS, Day 1- 12 hours00
Abnormal, NCS, Day 1- 12.5 hours15
Abnormal, CS, Day 1- 12.5 hours01
Abnormal, NCS, Day 1- 13 hours18
Abnormal, CS, Day 1- 13 hours00
Abnormal, NCS, Day 1- 13.5 hours210
Abnormal, CS, Day 1- 13.5 hours00
Abnormal, NCS, Day 1- 14 hours27
Abnormal, CS, Day 1- 14 hours00
Abnormal, NCS, Day 1- 14.5 hours29
Abnormal, CS, Day 1- 14.5 hours00
Abnormal, NCS, Day 1- 15 hours18
Abnormal, CS, Day 1- 15 hours00
Abnormal, NCS, Day 1- 16 hours19
Abnormal, CS, Day 1- 16 hours00
Abnormal, NCS, Day 1- 18 hours111
Abnormal, CS, Day 1- 18 hours00
Abnormal, NCS, Day 1- 20 hours110
Abnormal, CS, Day 1- 20 hours00
Abnormal, NCS, Day 2- 24 hours19
Abnormal, CS, Day 2- 24 hours00
Abnormal, NCS, Day 2- 36 hours18
Abnormal, CS, Day 2- 36 hours00
Abnormal, NCS, Day 3- 48 hours111
Abnormal, CS, Day 3- 48 hours00
Abnormal, NCS, Day 3- 60 hours15
Abnormal, CS, Day 3- 60 hours00
PrimaryPart 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings

A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame:
Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3
Reported as:
Count of participants · Participants
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
ParticipantsPart 1: PlaceboPart 1: Gepotidacin 3000 mg 6 Hour Interval
Abnormal, NCS, Day 1- predose111
Abnormal, CS, Day 1- predose00
Abnormal, NCS, Day 1- predose 209
Abnormal, CS, Day 1-predose 200
Abnormal, NCS, Day 1- predose 3110
Abnormal, CS, Day 1- predose 300
Abnormal, NCS, Day 1- 0.5 hours19
Abnormal, CS, Day 1- 0.5 hours00
Abnormal, NCS, Day 1- 1 hour19
Abnormal, CS, Day 1- 1 hour00
Abnormal, NCS, Day 1- 1.5 hours19
Abnormal, CS, Day 1- 1.5 hours00
Abnormal, NCS, Day 1- 2 hours19
Abnormal, CS, Day 1- 2 hours00
Abnormal, NCS, Day 1- 2.5 hours08
Abnormal, CS, Day 1- 2.5 hours00
Abnormal, NCS, Day 1- 3 hours19
Abnormal, CS, Day 1- 3 hours00
Abnormal, NCS, Day 1- 4 hours28
Abnormal, CS, Day 1- 4 hours00
Abnormal, NCS, Day 1- 6 hours27
Abnormal, CS, Day 1- 6 hours00
Abnormal, NCS, Day 1- 6.5 hours07
Abnormal, CS, Day 1- 6.5 hours00
Abnormal, NCS, Day 1- 7 hours07
Abnormal, CS, Day 1- 7 hours00
Abnormal, NCS, Day 1- 7.5 hours010
Abnormal, CS, Day 1- 7.5 hours00
Abnormal, NCS, Day 1- 8 hours111
Abnormal, CS, Day 1- 8 hours00
Abnormal, NCS, Day 1- 8.5 hours210
Abnormal, CS, Day 1- 8.5 hours00
Abnormal, NCS, Day 1- 9 hours111
Abnormal, CS, Day 1- 9 hours00
Abnormal, NCS, Day 1- 10 hours28
Abnormal, CS, Day 1- 10 hours00
Abnormal, NCS, Day 1- 12 hours16
Abnormal, CS, Day 1- 12 hours00
Abnormal, NCS, Day 1- 14 hours07
Abnormal, CS, Day 1- 14 hours00
Abnormal, NCS, Day 1- 18 hours110
Abnormal, CS, Day 1- 18 hours00
Abnormal, NCS, Day 2- 24 hours18
Abnormal, CS, Day 2- 24 hours00
Abnormal, NCS, Day 2- 36 hours010
Abnormal, CS, Day 2- 36 hours00
Abnormal, NCS, Day 3- 48 hours110
Abnormal, CS, Day 3- 48 hours00
Abnormal, NCS, Day 3- 60 hours08
Abnormal, CS, Day 3- 60 hours00
PrimaryPart 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings

A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame:
Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3
Reported as:
Count of participants · Participants
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
ParticipantsPart 2: PlaceboPart 2: Gepotidacin 1500 mg
Abnormal, NCS, Day 1- predose, n= 3, 1414
Abnormal, CS, Day 1- predose, n= 3, 1400
Abnormal, NCS, Day 1- predose 2, n= 3, 1405
Abnormal, CS, Day 1-predose 2, n= 3, 1400
Abnormal, NCS, Day 1- predose 3, n= 3, 1404
Abnormal, CS, Day 1- predose 3, n= 3, 1400
Abnormal, NCS, Day 1- 0.5 hours, n= 3, 1405
Abnormal, CS, Day 1- 0.5 hours, n= 3, 1400
Abnormal, NCS, Day 1- 1 hour, n= 3, 1307
Abnormal, CS, Day 1- 1 hour, n= 3, 1300
Abnormal, NCS, Day 1- 1.5 hours, n= 3, 1304
Abnormal, CS, Day 1- 1.5 hours, n= 3, 1300
Abnormal, NCS, Day 1- 2 hours, n= 3, 1304
Abnormal, CS, Day 1- 2 hours, n= 3, 1300
Abnormal, NCS, Day 1- 2.5 hours, n= 3, 1304
Abnormal, CS, Day 1- 2.5 hours, n= 3, 1300
Abnormal, NCS, Day 1- 3 hours, n= 3, 1316
Abnormal, CS, Day 1- 3 hours, n= 3, 1300
Abnormal, NCS, Day 1- 4 hours, n= 3, 1405
Abnormal, CS, Day 1- 4 hours, n= 3, 1400
Abnormal, NCS, Day 1- 6 hours, n= 3, 1306
Abnormal, CS, Day 1- 6 hours, n= 3, 1300
Abnormal, NCS, Day 1- 8 hours, n= 3, 1313
Abnormal, CS, Day 1- 8 hours, n= 3, 1300
Abnormal, NCS, Day 1- 12 hours, n= 3, 1306
Abnormal, CS, Day 1- 12 hours, n= 3, 1300
Abnormal, NCS, Day 1- 24 hours, n= 3, 1324
Abnormal, CS, Day 1- 24 hours, n= 3, 1300
Abnormal, NCS, Day 1- 36 hours, n= 3, 1303
Abnormal, CS, Day 1- 36 hours, n= 3, 1300
Abnormal, NCS, Day 1- 48 hours, n= 3, 1325
Abnormal, CS, Day 1- 48 hours, n= 3, 1300
PrimaryPart 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings

A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame:
Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3
Reported as:
Count of participants · Participants
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
ParticipantsPart 2: PlaceboPart 2: Gepotidacin 3000 mg 6 Hour Interval
Abnormal, NCS, Day 1- predose16
Abnormal, CS, Day 1- predose00
Abnormal, NCS, Day 1- predose 217
Abnormal, CS, Day 1-predose 200
Abnormal, NCS, Day 1- predose 317
Abnormal, CS, Day 1- predose 300
Abnormal, NCS, Day 1- 0.5 hours16
Abnormal, CS, Day 1- 0.5 hours00
Abnormal, NCS, Day 1- 1 hour16
Abnormal, CS, Day 1- 1 hour00
Abnormal, NCS, Day 1- 1.5 hours04
Abnormal, CS, Day 1- 1.5 hours00
Abnormal, NCS, Day 1- 2 hours06
Abnormal, CS, Day 1- 2 hours00
Abnormal, NCS, Day 1- 2.5 hours05
Abnormal, CS, Day 1- 2.5 hours00
Abnormal, NCS, Day 1- 3 hours05
Abnormal, CS, Day 1- 3 hours00
Abnormal, NCS, Day 1- 4 hours15
Abnormal, CS, Day 1- 4 hours00
Abnormal, NCS, Day 1- 6 hours13
Abnormal, CS, Day 1- 6 hours00
Abnormal, NCS, Day 1- 6.5 hours15
Abnormal, CS, Day 1- 6.5 hours00
Abnormal, NCS, Day 1- 7 hours15
Abnormal, CS, Day 1- 7 hours00
Abnormal, NCS, Day 1- 7.5 hours03
Abnormal, CS, Day 1- 7.5 hours00
Abnormal, NCS, Day 1- 8 hours03
Abnormal, CS, Day 1- 8 hours00
Abnormal, NCS, Day 1- 8.5 hours03
Abnormal, CS, Day 1- 8.5 hours00
Abnormal, NCS, Day 1- 9 hours04
Abnormal, CS, Day 1- 9 hours00
Abnormal, NCS, Day 1- 10 hours15
Abnormal, CS, Day 1- 10 hours00
Abnormal, NCS, Day 1- 12 hours04
Abnormal, CS, Day 1- 12 hours00
Abnormal, NCS, Day 1- 14 hours04
Abnormal, CS, Day 1- 14 hours00
Abnormal, NCS, Day 1- 18 hours17
Abnormal, CS, Day 1- 18 hours00
Abnormal, NCS, Day 1- 24 hours16
Abnormal, CS, Day 1- 24 hours00
Abnormal, NCS, Day 1- 36 hours04
Abnormal, CS, Day 1- 36 hours00
Abnormal, NCS, Day 1- 48 hours27
Abnormal, CS, Day 1- 48 hours00
SecondaryPart 1- Period 1: Total Unchanged Drug (Ae Total) After Single Dose Administration of Gepotidacin 1500 mg

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Milligrams
Part 1- Period 1: Total Unchanged Drug (Ae Total) After Single Dose Administration of Gepotidacin 1500 mg
MilligramsPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Total Unchanged Drug (Ae Total) After Single Dose Administration of Gepotidacin 1500 mg328.1 ± 68.09
SecondaryPart 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg

Urine samples were collected at the specified intervals for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

Time frame:
0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Milligrams
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
MilligramsPart 1: Gepotidacin 1500 mg
Ae (0-2), n=1450.87 ± 61.194
Ae (2-4), n=1392.98 ± 51.315
Ae (4-6), n=1368.14 ± 39.927
Ae (6-8), n=1447.68 ± 25.551
Ae (8-12), n=1435.71 ± 11.458
Ae (12-24), n=1429.10 ± 7.8849
Ae (24-36), n=1310.72 ± 4.2330
Ae (36-48), n=135.601 ± 2.0351
SecondaryPart 1- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose.
Reported as:
Mean · Hours*micrograms per milliliter
Part 1- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
Hours*micrograms per milliliterPart 1: Gepotidacin 1500 mg
Part 1- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)3340.0 ± 2340.34
SecondaryPart 1- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)

Urine samples were be collected at indicated time points for pharmacokinetic analysis of gepotidacin.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 1- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
Hours*micrograms per milliliterPart 1: Gepotidacin 1500 mg
Part 1- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)3567.9 ± 2377.71
SecondaryPart 1- Period 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) After Single Dose Administration of Gepotidacin 1500 mg

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100 percent (%).

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Percent dose excreted
Part 1- Period 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) After Single Dose Administration of Gepotidacin 1500 mg
Percent dose excretedPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) After Single Dose Administration of Gepotidacin 1500 mg21.874 ± 4.5393
SecondaryPart 1- Period 1: Renal Clearance of Drug (CLr) After Single Dose Administration of Gepotidacin 1500 mg

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Liters per hour
Part 1- Period 1: Renal Clearance of Drug (CLr) After Single Dose Administration of Gepotidacin 1500 mg
Liters per hourPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Renal Clearance of Drug (CLr) After Single Dose Administration of Gepotidacin 1500 mg16.66 ± 3.4123
SecondaryPart 1- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose
Reported as:
Mean · Milligrams
Part 1- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
MilligramsPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval1452.7 ± 223.10
SecondaryPart 1- Period 3: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose
Reported as:
Mean · Milligrams
Part 1- Period 3: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
MilligramsPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval1293.9 ± 367.48
SecondaryPart 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals

Time frame:
0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose
Reported as:
Mean · Milligrams
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
MilligramsPart 1: Gepotidacin 3000 mg 12 Hour Interval
Ae (0-2), n=13158.5 ± 81.599
Ae (2-4), n=12186.1 ± 73.777
Ae (4-6), n=13143.6 ± 73.790
Ae (6-8), n=1266.80 ± 22.886
Ae (8-12), n=1364.98 ± 23.987
Ae (12-14), n=12204.1 ± 113.98
Ae (14-16), n=13254.3 ± 83.985
Ae (16-18), n=12156.7 ± 85.023
Ae (18-20), n=1380.29 ± 43.563
Ae (20-24), n=1379.23 ± 25.216
Ae (24-36), n=1374.53 ± 21.862
Ae (36-48), n=1320.35 ± 5.7977
Ae (48-60), n=1310.51 ± 5.0038
SecondaryPart 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

Time frame:
0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18 -24, 24-36, 36-48 and 48-60 hours post-dose
Reported as:
Mean · Milligrams
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
MilligramsPart 1: Gepotidacin 3000 mg 6 Hour Interval
Ae (0-2), n=1297.51 ± 70.551
Ae (2-4), n=10216.8 ± 97.543
Ae (4-6), n=13172.2 ± 98.842
Ae (6-8), n=12242.3 ± 138.61
Ae (8-10), n=11251.0 ± 115.23
Ae (10-12), n=12151.6 ± 91.694
Ae (12-14), n=12107.3 ± 77.898
Ae (14-18), n=1272.83 ± 27.363
Ae (18-24), n=1263.91 ± 48.404
Ae (24-36), n=1339.13 ± 12.057
Ae (36-48), n=1315.64 ± 5.9580
Ae (48-60), n=138.889 ± 4.1747
SecondaryPart 1- Period 2: AUC(0-tau) (Tau=12 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8 and 8-12 hours post-dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 1- Period 2: AUC(0-tau) (Tau=12 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: AUC(0-tau) (Tau=12 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)7287.4 ± 4050.81
SecondaryPart 1- Period 3: AUC(0-tau) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin

Time frame:
Pre-dose, 0-2, 2-4 and 4-6 hours post-dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 1- Period 3: AUC(0-tau) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: AUC(0-tau) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)3943.5 ± 3015.98
SecondaryPart 1- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20 and 20-24 hours post dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 1- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)17431.6 ± 10132.84
SecondaryPart 1- Period 3: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 1- Period 3: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)13174.1 ± 8648.92
SecondaryPart 1- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 1- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)19128.3 ± 10934.06
SecondaryPart 1- Period 3: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 1- Period 3: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)
Hours*micrograms per milliliterPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)14277.1 ± 9045.37
SecondaryPart 1- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose
Reported as:
Mean · Percent dose excreted
Part 1- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Percent dose excretedPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval24.212 ± 3.7184
SecondaryPart 1- Period 3: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose
Reported as:
Mean · Percent dose excreted
Part 1- Period 3: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Percent dose excretedPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval21.565 ± 6.1246
SecondaryPart 1- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose
Reported as:
Mean · Liters per hour
Part 1- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Liters per hourPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval15.88 ± 2.0305
SecondaryPart 1- Period 3: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose
Reported as:
Mean · Liters per hour
Part 1- Period 3: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Liters per hourPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval14.81 ± 3.4456
SecondaryPart 2- Period 1: Ae Total After Single Dose Administration of Gepotidacin 1500 mg

Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Milligrams
Part 2- Period 1: Ae Total After Single Dose Administration of Gepotidacin 1500 mg
MilligramsPart 2: Gepotidacin 1500 mg
Part 2- Period 1: Ae Total After Single Dose Administration of Gepotidacin 1500 mg361.5 ± 83.95
SecondaryPart 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

Time frame:
0-2, 2-4, 4-6, 6-8, 8-12, 12-24,24-36 and 36-48 hours post-dose
Reported as:
Mean · Milligrams
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
MilligramsPart 2: Gepotidacin 1500 mg
Ae (0-2), n=1316.00 ± 28.532
Ae (2-4), n=12130.5 ± 49.526
Ae (4-6), n=1285.47 ± 37.814
Ae (6-8), n=1358.74 ± 32.586
Ae (8-12), n=1340.15 ± 14.232
Ae (12-24), n=1330.87 ± 11.638
Ae (24-36), n=1310.11 ± 4.6348
Ae (36-48), n=136.312 ± 2.5619
SecondaryPart 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose.
Reported as:
Mean · Hours*micrograms per milliliter
Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
Hours*micrograms per milliliterPart 2: Gepotidacin 1500 mg
Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)4513.7 ± 2623.81
SecondaryPart 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
Hours*micrograms per milliliterPart 2: Gepotidacin 1500 mg
Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)4948.4 ± 2721.49
SecondaryPart 2- Period 1: fe% After Single Dose Administration of Gepotidacin 1500 mg

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Percent dose excreted
Part 2- Period 1: fe% After Single Dose Administration of Gepotidacin 1500 mg
Percent dose excretedPart 2: Gepotidacin 1500 mg
Part 2- Period 1: fe% After Single Dose Administration of Gepotidacin 1500 mg24.100 ± 5.5968
SecondaryPart 2- Period 1: CLr After Single Dose Administration of Gepotidacin 1500 mg

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Liters per hour
Part 2- Period 1: CLr After Single Dose Administration of Gepotidacin 1500 mg
Liters per hourPart 2: Gepotidacin 1500 mg
Part 2- Period 1: CLr After Single Dose Administration of Gepotidacin 1500 mg15.56 ± 3.7934
SecondaryPart 2- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Milligrams
Part 2- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
MilligramsPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval1719.4 ± 402.71
SecondaryPart 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

Time frame:
0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Milligrams
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
MilligramsPart 2: Gepotidacin 3000 mg 6 Hour Interval
Ae (0-2), n=11105.3 ± 121.67
Ae (2-4), n=10202.0 ± 70.108
Ae (4-6), n=10229.7 ± 113.95
Ae (6-8), n=11244.9 ± 149.66
Ae (8-10), n=12446.6 ± 138.33
Ae (10-12), n=10228.3 ± 79.619
Ae (12-14), n=11172.5 ± 63.150
Ae (14-18), n=10132.6 ± 51.586
Ae (18-24), n=1067.56 ± 40.521
Ae (24-36), n=1261.99 ± 51.367
Ae (36-48), n=1214.86 ± 8.3210
SecondaryPart 2- Period 2: AUC(0-tau) (Tau=6 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)

Urine samples will be collected at indicated time points for pharmacokinetic analysis of gepotidacin

Time frame:
Pre-dose, 0-2, 2-4, 4-6 hours post-dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 2- Period 2: AUC(0-tau) (Tau=6 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)
Hours*micrograms per milliliterPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: AUC(0-tau) (Tau=6 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)5364.4 ± 2877.94
SecondaryPart 2- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dose
Reported as:
Mean · Hours*micrograms per milliliter
Part 2- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)
Hours*micrograms per milliliterPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)22052.8 ± 11410.09
SecondaryPart 2- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)

Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose.
Reported as:
Mean · Hours*micrograms per milliliter
Part 2- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)
Hours*micrograms per milliliterPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)24500.7 ± 12281.23
SecondaryPart 2- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Percent dose excreted
Part 2- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Percent dose excretedPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval28.657 ± 6.7119
SecondaryPart 2- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).

Time frame:
Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Reported as:
Mean · Liters per hour
Part 2- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Liters per hourPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval14.93 ± 3.9558
SecondaryPart 1- Period 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Median · Hours
Part 1- Period 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Dose Administration of Gepotidacin 1500 mg
HoursPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Dose Administration of Gepotidacin 1500 mg3.000 (0.50 to 6.00)
SecondaryPart 1- Period 1: Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Median · Hours
Part 1- Period 1: Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) After Single Dose Administration of Gepotidacin 1500 mg
HoursPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) After Single Dose Administration of Gepotidacin 1500 mg0.000 (0.00 to 1.50)
SecondaryPart 1- Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours
Part 1- Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of Gepotidacin 1500 mg
HoursPart 1: Gepotidacin 1500 mg
Part 1- Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of Gepotidacin 1500 mg11.533 ± 36.2
SecondaryPart 1- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Reported as:
Median · Hours
Part 1- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
HoursPart 1: Gepotidacin 3000 mg 12 Hour Interval
Dose 12.000 (1.00 to 4.00)
Dose 21.567 (1.00 to 4.00)
SecondaryPart 1- Period 3: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Reported as:
Median · Hours
Part 1- Period 3: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
HoursPart 1: Gepotidacin 3000 mg 6 Hour Interval
Dose 12.633 (0.50 to 5.42)
Dose 21.500 (1.00 to 3.28)
SecondaryPart 1- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Reported as:
Median · Hours
Part 1- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
HoursPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval0.000 (0.00 to 0.00)
SecondaryPart 1- Period 3: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Reported as:
Median · Hours
Part 1- Period 3: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
HoursPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval0.000 (0.00 to 0.00)
SecondaryPart 1- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Hours
Part 1- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
HoursPart 1: Gepotidacin 3000 mg 12 Hour Interval
Part 1- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval10.976 ± 27.3
SecondaryPart 1- Period 3: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Reported as:
Geometric mean · Hours
Part 1- Period 3: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
HoursPart 1: Gepotidacin 3000 mg 6 Hour Interval
Part 1- Period 3: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval12.020 ± 14.6
SecondaryPart 2- Period 1: Tmax After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Median · Hours
Part 2- Period 1: Tmax After Single Dose Administration of Gepotidacin 1500 mg
HoursPart 2: Gepotidacin 1500 mg
Part 2- Period 1: Tmax After Single Dose Administration of Gepotidacin 1500 mg3.000 (1.50 to 6.50)
SecondaryPart 2- Period 1: Tlag After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Median · Hours
Part 2- Period 1: Tlag After Single Dose Administration of Gepotidacin 1500 mg
HoursPart 2: Gepotidacin 1500 mg
Part 2- Period 1: Tlag After Single Dose Administration of Gepotidacin 1500 mg0.500 (0.00 to 1.50)
SecondaryPart 2- Period 1: t1/2 After Single Dose Administration of Gepotidacin 1500 mg

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours
Part 2- Period 1: t1/2 After Single Dose Administration of Gepotidacin 1500 mg
HoursPart 2: Gepotidacin 1500 mg
Part 2- Period 1: t1/2 After Single Dose Administration of Gepotidacin 1500 mg12.984 ± 16.6
SecondaryPart 2- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Reported as:
Median · Hours
Part 2- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
HoursPart 2: Gepotidacin 3000 mg 6 Hour Interval
Dose 12.750 (1.00 to 4.00)
Dose 21.500 (1.00 to 3.00)
SecondaryPart 2- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Reported as:
Median · Hours
Part 2- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
HoursPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval0.000 (0.00 to 0.50)
SecondaryPart 2- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval

Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.

Time frame:
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Reported as:
Geometric mean · Hours
Part 2- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
HoursPart 2: Gepotidacin 3000 mg 6 Hour Interval
Part 2- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval6.982 ± 19.7

Adverse events

Collected over Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part 1 : Placebo0/2 (0%)0/2 (0%)0/2 (0%)
Part1: Gepotidacin 1500 mg0/14 (0%)0/14 (0%)1/14 (7.1%)
Part 1: Gepotidacin 3000 mg 12 Hour Interval0/13 (0%)0/13 (0%)10/13 (76.9%)
Part 1: Gepotidacin 3000 mg 6 Hour Interval0/13 (0%)0/13 (0%)9/13 (69.2%)
Part 2 : Placebo0/3 (0%)0/3 (0%)2/3 (66.7%)
Part 2: Gepotidacin 1500 mg0/14 (0%)0/14 (0%)9/14 (64.3%)
Part 2: Gepotidacin 3000 mg 6 Hour Interval0/12 (0%)0/12 (0%)12/12 (100%)
Most frequent other events
Showing 10 of 17
Most frequent other events
EventPart 1 : PlaceboPart1: Gepotidacin 1500 mgPart 1: Gepotidacin 3000 mg 12 Hour IntervalPart 1: Gepotidacin 3000 mg 6 Hour IntervalPart 2 : PlaceboPart 2: Gepotidacin 1500 mgPart 2: Gepotidacin 3000 mg 6 Hour Interval
NauseaGastrointestinal disorders0/20/142/133/131/30/149/12
DiarrhoeaGastrointestinal disorders0/21/148/138/131/33/145/12
VomitingGastrointestinal disorders0/20/141/132/130/30/145/12
Abdominal discomfortGastrointestinal disorders0/20/144/134/131/32/143/12
DizzinessNervous system disorders0/20/140/130/131/30/144/12
HeadacheNervous system disorders0/20/140/130/131/32/141/12
SyncopeNervous system disorders0/20/140/130/131/30/140/12
FlatulenceGastrointestinal disorders0/20/140/130/130/32/142/12
Supraventricular extrasystolesCardiac disorders0/20/140/130/130/30/141/12
Chest discomfortGeneral disorders0/20/140/130/130/30/141/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Gepotidacin (A/C/E)Placebo (B/D/F)Gepotidacin (A/G)Placebo (B/H)Total
<=18 years0014317
Between 18 and 65 years1420016
>=65 years00000
Sex: Female, Male
Sex: Female, Male(Participants)Gepotidacin (A/C/E)Placebo (B/D/F)Gepotidacin (A/G)Placebo (B/H)Total
Female614112
Male8110221
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Gepotidacin (A/C/E)Placebo (B/D/F)Gepotidacin (A/G)Placebo (B/H)Total
Asian- Central/South Asian Heritage10102
Black or African American606113
White-Arabic/North African Heritage10001
White-White/Caucasian/European Heritage625215
Multiple00202
08

Study locations

1 site
  • GSK Investigational Site
    Las Vegas, Nevada 89113, United States
09

References and documents

Publications

  • Barth A, Hossain M, Brimhall DB, Perry CR, Tiffany CA, Xu S, Dumont EF. Pharmacokinetics of Oral Formulations of Gepotidacin (GSK2140944), a Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor, in Healthy Adult and Adolescent Participants. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0126321. doi: 10.1128/AAC.01263-21. Epub 2021 Oct 11. PubMed 34633853 ↗

Study documents

  • Study protocol · Jun 13, 2019
  • Statistical analysis plan · Dec 10, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04079790
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 6, 2019
Start date
Sep 4, 2019
Primary completion
Nov 25, 2019
Completion
Nov 25, 2019
Results posted
Sep 4, 2020
Last update
Sep 4, 2020

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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