A Phase 1 interventional study of AZD0914 in Gonorrhoea, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-18.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
The trial is to evaluate the pharmacokinetics and safety profiles of the single-dose of zoliflodacin in eight healthy male or female subjects ages 18 to 45 years inclusive. All subjects will be dosed in the morning of Day 1 in a staggered fashion with a minimum of several minutes apart. Each subject will receive a single 4g dose of zoliflodacin (2 x 2 g sachets of zoliflodacin) after at least an 8-h fast, which will continue for at least 4 h after dosing. Consumption of water will be permitted during the fasting period. Subjects will be monitored as inpatients in the Clinical Trial Unit (CTU) up to Day 4 and at the Final Visit (Day 8 ± 2). Study duration is approximately 4 weeks with subject participation duration up to 10 days (from dosing to final visit). The primary objective of this study is to evaluate the plasma PK of zoliflodacin after administration of a single 4-g oral dose under fasting conditions.
The trial will be performed as an open-label, non-randomized, single-dose design in eight healthy male or female subjects ages 18 to 45 years inclusive to evaluate the pharmacokinetics and safety profiles of the zoliflodacin formulation. All subjects will be dosed in the morning of Day 1 in a staggered fashion with a minimum of several minutes apart. Each subject will receive a single 4g dose of zoliflodacin (2 x 2 g sachets of zoliflodacin) after at least an 8-h fast, which will continue for at least 4 h after dosing. Consumption of water will be permitted during the fasting period. Subjects will be monitored as inpatients in the Clinical Trial Unit (CTU) up to Day 4 and at the Final Visit (Day 8 ± 2). Study duration is approximately 4 weeks with subject participation duration up to 10 days (from dosing to final visit). The primary objective of this study is to evaluate the plasma PK of zoliflodacin after administration of a single 4-g oral dose under fasting conditions. The secondary objective is to evaluate the safety and tolerability of a single 4-g oral dose of zoliflodacin.
167 studies on the registry are indexed under Gonorrhea; 31 are open to participants now.
This study's enrollment of 8 is below the median of 400 across 125 interventional studies indexed under Gonorrhea.
Browse Gonorrhea studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In female subjects of , a negative serum pregnancy test at Screening Visit and on Day -1
Females of childbearing potential and males agree to use acceptable for the duration of the trial and for 30 days (females) or 90 days (males) after final study visit
Exclusion Criteria:
Note: Chronic medical conditions include: diabetes mellitus; asthma requiring use of medication in the year before screening; disorder such as lupus erythematosus, Wegener's, rheumatoid arthritis, thyroid disease; cardiovascular disease, including coronary artery disease or cerebrovascular disease, or surgery; syncope related to cardiac arrhythmia or unexplained; chronic hypertension; except low-grade (squamous and basal cell) skin cancer thought to be cured; chronic renal, hepatic, pulmonary, or endocrine disease, myopathy, or neuropathy; gastrointestinal or biliary surgery.
Note 2: Allowed medications include: oral ; H1 antihistamines; topical/ intranasal corticosteroids; nonsteroidal anti-inflammatory drugs [NSAIDS]; licensed influenza vaccine during the flu season, 7 days before or after dosing.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 g (2 sachets of 2 g) of zoliflodacin orally in the morning of Day 1 after 8 hours of fasting, n=8
Drug: AZD0914
Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent
Maximum Observed Concentration (Cmax) of Zoliflodacin
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.
Time frame: From Day 1 to Day 4
Time of Maximum Observed Concentration (Tmax) of Zoliflodacin
Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLC-MS/MS method.
Time frame: From Day 1 to Day 4
Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Zoliflodacin
AUC(0-8) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-8) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLC-MS/MS method.
Time frame: From Day 1 to Day 4
Area Under the Concentration Time-curve From Time Zero to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-last)) for Zoliflodacin
AUC(0-last) was defined as the area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration computed from concentrations that were measured using a validated HPLC-MS/MS method.
Time frame: From Day 1 to Day 4
Apparent Volume of Distribution (Vz/F) of Zoliflodacin
Apparent volume of distribution during terminal phase (Vz/F) after non-intravenous administration was calculated as (CL/F)/ Ke computed from concentrations that were measured using a validated HPLC-MS/MS method.
Time frame: From Day 1 to Day 4
Apparent Oral Clearance (CL/F) of Zoliflodacin
Apparent oral clearance (CL/F) computed as Dose/Area under the curve (AUC) from time zero to infinity (0-8) computed from concentrations that were measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method.
Time frame: Day 1 to Day 4
Elimination Rate Constant (Ke) of Zoliflodacin
The terminal phase elimination rate constant (Ke) was defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase (defined as the terminal region of the PK curve where drug concentration follows first-order elimination kinetics) computed from concentrations that were measured using a validated HPLC-MS/MS method.
Time frame: From Day 1 to Day 4
Terminal Elimination Half-life (t1/2) of Zoliflodacin
The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLC-MS/MS method.
Time frame: From Day 1 to Day 4
Changes From Baseline for White Blood Cells With Differentials and Platelets
Change from baseline calculated by subtracting the Day -1 (baseline) hematology measurement from the Day 4 hematology measurement. Hematology parameters included white blood cell count, differential (absolute counts of neutrophils, lymphocytes, monocytes, eosinophils, and basophils), and platelet count.
Time frame: From Day -1 through Day 4
Changes From Baseline Hematocrit
Change from baseline calculated by subtracting the Day -1 (baseline) hematocrit measurement from the Day 4 hematocrit measurement.
Time frame: From Day -1 through Day 4
Changes From Baseline Hemoglobin
Change from baseline calculated by subtracting the Day -1 (baseline) hemoglobin measurement from the Day 4 hemoglobin measurement.
Time frame: From Day -1 through Day 4
Changes From Baseline Red Blood Cell Count
Change from baseline calculated by subtracting the Day -1 (baseline) red blood cell count measurement from the Day 4 red blood cell count measurement.
Time frame: From Day -1 through Day 4
Changes From Baseline for Albumin and Total Protein
Change from baseline calculated by subtracting the Day -1 (baseline) albumin or total protein measurement from the Day 4 albumin or total protein measurement.
Time frame: From Day -1 through Day 4
Change From Baseline for Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
Change from baseline calculated by subtracting the Day -1 (baseline) AP, ALT, or AST measurement from the Day 4 AP, ALT, or AST measurement.
Time frame: From Day -1 through Day 4
Change From Baseline for Blood Urea Nitrogen (BUN), Serum Creatinine, Glucose (Fasting at Least 4h), Magnesium, Total and Direct Bilirubin
Change from baseline calculated by subtracting the Day -1 (baseline) serum chemistry measurement from the Day 4 serum chemistry measurement. Serum chemistry tests for this outcome measure included BUN, creatinine, fasting glucose, magnesium, total bilirubin, and direct bilirubin.
Time frame: From Day -1 through Day 4
Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Change from baseline calculated by subtracting the Day -1 (baseline) serum chemistry measurement from the Day 4 serum chemistry measurement. Serum chemistry tests for this outcome measure included sodium, potassium, chloride, and bicarbonate.
Time frame: From Day -1 through Day 4
Changes From Baseline for Blood Pressure - Systolic
Change from baseline in systolic blood pressure calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time frame: From Day -1 through Day 8
Changes From Baseline for Blood Pressure - Diastolic
Change from baseline in diastolic blood pressure calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time frame: From Day -1 through Day 8
Changes From Baseline in Oral Temperature
Change from baseline in temperature calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time frame: From Day -1 through Day 8
Changes From Baseline in Pulse Rate
Change from baseline in pulse rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time frame: From Day -1 through Day 8
Changes From Baseline for Respiratory Rate
Change from baseline in respiratory rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time frame: From Day -1 through Day 8
Changes From Baseline in ECG: PR Interval (Interval From Onset of P-wave to the Onset of the QRS Complex)
Change from baseline in ECG PR Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
Time frame: From Day -1 through Day 4
Changes From Baseline in ECG: QRS Duration (Time From the Start of the Q-wave to the End of the S-wave)
Change from baseline in ECG QRS Duration calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
Time frame: From Day -1 through Day 4
Changes From Baseline in ECG: QTcF Interval (QT Interval Corrected by Fridericia's Formula)
Change from baseline in ECG QTcF Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
Time frame: From Day -1 through Day 4
Changes From Baseline in ECG: QT Interval (Interval From Onset of the Q-wave to the End of the T-wave)
Change from baseline in ECG QT Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
Time frame: From Day -1 through Day 4
Changes From Baseline in ECG: RR Interval (Interval From the Peak of the R Wave of a QRS Complex to the Peak of the R Wave of the Next QRS Complex)
Change from baseline in ECG RR Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
Time frame: From Day -1 through Day 4
Changes From Baseline in ECG: Ventricular Rate
Change from baseline in ECG Ventricular Rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
Time frame: From Day -1 through Day 4
Changes From Baseline for Occult Blood Via Dipstick
Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for occult blood were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.
Time frame: From Day -1 through Day 4
Changes From Baseline for Glucose Via Dipstick
Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for glucose were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.
Time frame: From Day -1 through Day 4
Changes From Baseline for Protein Via Dipstick
Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for protein were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.
Time frame: From Day -1 through Day 4
Occurrence of Unsolicited Treatment-emergent Adverse Events
Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment.
Time frame: From study product administration (Day 1) to Day 8
Occurrence of Treatment-emergent Serious Adverse Events
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect.
Time frame: From study product administration (Day 1) to Day 8
The trial was performed at a commercial phase 1 unit. Recruitment opened on February 2, 2018 and all eight participants were consented and screened for meeting eligibility criteria prior to enrollment and dosing on Feb 23, 2018.
| Milestone | Zoliflodacin |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.
| ng/mL | Zoliflodacin |
|---|---|
| Maximum Observed Concentration (Cmax) of Zoliflodacin | 20863 ± 7129 |
Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLC-MS/MS method.
| hour | Zoliflodacin |
|---|---|
| Time of Maximum Observed Concentration (Tmax) of Zoliflodacin | 4 ± 3 |
AUC(0-8) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-8) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLC-MS/MS method.
| h x ng/mL | Zoliflodacin |
|---|---|
| Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Zoliflodacin | 226750 ± 85336 |
AUC(0-last) was defined as the area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration computed from concentrations that were measured using a validated HPLC-MS/MS method.
| h x ng/mL | Zoliflodacin |
|---|---|
| Area Under the Concentration Time-curve From Time Zero to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-last)) for Zoliflodacin | 226500 ± 85340 |
Apparent volume of distribution during terminal phase (Vz/F) after non-intravenous administration was calculated as (CL/F)/ Ke computed from concentrations that were measured using a validated HPLC-MS/MS method.
| Liter | Zoliflodacin |
|---|---|
| Apparent Volume of Distribution (Vz/F) of Zoliflodacin | 183.6 ± 58.8 |
Apparent oral clearance (CL/F) computed as Dose/Area under the curve (AUC) from time zero to infinity (0-8) computed from concentrations that were measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method.
| L/h | Zoliflodacin |
|---|---|
| Apparent Oral Clearance (CL/F) of Zoliflodacin | 19.9 ± 7.0 |
The terminal phase elimination rate constant (Ke) was defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase (defined as the terminal region of the PK curve where drug concentration follows first-order elimination kinetics) computed from concentrations that were measured using a validated HPLC-MS/MS method.
| 1/hour | Zoliflodacin |
|---|---|
| Elimination Rate Constant (Ke) of Zoliflodacin | 0.108 ± 0.011 |
The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLC-MS/MS method.
| hour | Zoliflodacin |
|---|---|
| Terminal Elimination Half-life (t1/2) of Zoliflodacin | 6.5 ± 0.6 |
Change from baseline calculated by subtracting the Day -1 (baseline) hematology measurement from the Day 4 hematology measurement. Hematology parameters included white blood cell count, differential (absolute counts of neutrophils, lymphocytes, monocytes, eosinophils, and basophils), and platelet count.
| 10^9/L | Zoliflodacin |
|---|---|
| Leukocytes | -0.659 ± 1.668 |
| Neutrophils | -0.118 ± 0.950 |
| Lymphocytes | -0.465 ± 0.689 |
| Monocytes | -0.036 ± 0.075 |
| Eosinophils | -0.035 ± 0.096 |
| Basophils | -0.008 ± 0.019 |
| Platelets | -7.1 ± 21.9 |
Change from baseline calculated by subtracting the Day -1 (baseline) hematocrit measurement from the Day 4 hematocrit measurement.
| percentage | Zoliflodacin |
|---|---|
| Changes From Baseline Hematocrit | 1.36 ± 1.68 |
Change from baseline calculated by subtracting the Day -1 (baseline) hemoglobin measurement from the Day 4 hemoglobin measurement.
| g/dL | Zoliflodacin |
|---|---|
| Changes From Baseline Hemoglobin | 0.46 ± 0.66 |
Change from baseline calculated by subtracting the Day -1 (baseline) red blood cell count measurement from the Day 4 red blood cell count measurement.
| 10^12/L | Zoliflodacin |
|---|---|
| Changes From Baseline Red Blood Cell Count | 0.150 ± 0.201 |
Change from baseline calculated by subtracting the Day -1 (baseline) albumin or total protein measurement from the Day 4 albumin or total protein measurement.
| g/dL | Zoliflodacin |
|---|---|
| Albumin | 0.02 ± 0.23 |
| Total Protein | 0.11 ± 0.29 |
Change from baseline calculated by subtracting the Day -1 (baseline) AP, ALT, or AST measurement from the Day 4 AP, ALT, or AST measurement.
| U/L | Zoliflodacin |
|---|---|
| Alkaline Phosphatase | -3.1 ± 7.2 |
| Alanine Aminotransferase | 1.5 ± 4.3 |
| Aspartate Aminotransferase | -0.8 ± 2.7 |
Change from baseline calculated by subtracting the Day -1 (baseline) serum chemistry measurement from the Day 4 serum chemistry measurement. Serum chemistry tests for this outcome measure included BUN, creatinine, fasting glucose, magnesium, total bilirubin, and direct bilirubin.
| mg/dL | Zoliflodacin |
|---|---|
| BUN | -3.0 ± 2.1 |
| Creatinine | 0.05 ± 0.08 |
| Glucose (fasting) | -2.6 ± 3.2 |
| Magnesium | -0.01 ± 0.08 |
| Total Bilirubin | 0.03 ± 0.31 |
| Direct Bilirubin | -0.01 ± 0.06 |
Change from baseline calculated by subtracting the Day -1 (baseline) serum chemistry measurement from the Day 4 serum chemistry measurement. Serum chemistry tests for this outcome measure included sodium, potassium, chloride, and bicarbonate.
| mmol/L | Zoliflodacin |
|---|---|
| Sodium | -1.1 ± 1.7 |
| Potassium | -0.24 ± 0.36 |
| Chloride | -3.6 ± 0.9 |
| Bicarbonate | 0.5 ± 1.2 |
Change from baseline in systolic blood pressure calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
| mmHg | Zoliflodacin |
|---|---|
| 1 Hour | 1.1 ± 3.9 |
| 2 Hour | 0 ± 5.9 |
| 4 Hour | -3.9 ± 6.0 |
| Day 2 | -1.1 ± 5.6 |
| Day 3 | -3.6 ± 7.4 |
| Day 4 | 0.5 ± 6.5 |
| Day 8 | 2.4 ± 11.4 |
Change from baseline in diastolic blood pressure calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
| mmHg | Zoliflodacin |
|---|---|
| 1 Hour | 0.1 ± 5.5 |
| 2 Hour | -5.3 ± 6.1 |
| 4 Hour | -4.5 ± 6.3 |
| Day 2 | -2.8 ± 7.5 |
| Day 3 | -4.1 ± 6.5 |
| Day 4 | 0.0 ± 6.3 |
| Day 8 | -1.0 ± 10.7 |
Change from baseline in temperature calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
| Degress C | Zoliflodacin |
|---|---|
| 1 Hour | -0.04 ± 0.29 |
| 2 Hour | 0.03 ± 0.17 |
| 4 Hour | 0.01 ± 0.24 |
| Day 2 | -0.06 ± 0.17 |
| Day 3 | -0.09 ± 0.16 |
| Day 4 | 0.06 ± 0.21 |
| Day 8 | -0.04 ± 0.23 |
Change from baseline in pulse rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
| Beats per minute | Zoliflodacin |
|---|---|
| 1 Hour | -3.8 ± 11.7 |
| 2 Hour | -0.4 ± 14.0 |
| 4 Hour | -3.5 ± 12.6 |
| Day 2 | -4.3 ± 12.8 |
| Day 3 | -1.8 ± 8.7 |
| Day 4 | -1.9 ± 13.3 |
| Day 8 | 1.9 ± 14.0 |
Change from baseline in respiratory rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
| Breaths per minute | Zoliflodacin |
|---|---|
| 1 Hour | 0.3 ± 1.7 |
| 2 Hour | 1.0 ± 2.1 |
| 4 Hour | 0.8 ± 2.4 |
| Day 2 | 0.8 ± 1.0 |
| Day 3 | 0.5 ± 0.9 |
| Day 4 | 0.5 ± 1.4 |
| Day 8 | 0.5 ± 1.8 |
Change from baseline in ECG PR Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
| msec | Zoliflodacin |
|---|---|
| 1 Hour | 4.0 ± 8.6 |
| 2 Hour | 2.3 ± 6.6 |
| 4 Hour | 1.5 ± 7.9 |
| 72 Hour | 6.9 ± 7.7 |
Change from baseline in ECG QRS Duration calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
| msec | Zoliflodacin |
|---|---|
| 1 Hour | -0.3 ± 3.3 |
| 2 Hour | 0.5 ± 2.7 |
| 4 Hour | -0.1 ± 2.7 |
| 72 Hour | 1.0 ± 3.9 |
Change from baseline in ECG QTcF Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
| msec | Zoliflodacin |
|---|---|
| 1 Hour | 1.8 ± 13.6 |
| 2 Hour | 6.8 ± 13.2 |
| 4 Hour | 4.0 ± 11.6 |
| 72 Hour | -2.6 ± 11.2 |
Change from baseline in ECG QT Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
| msec | Zoliflodacin |
|---|---|
| 1 Hour | -1.1 ± 13.8 |
| 2 Hour | 4.6 ± 15.6 |
| 4 Hour | 3.6 ± 10.8 |
| 72 Hour | -6.3 ± 8.8 |
Change from baseline in ECG RR Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
| msec | Zoliflodacin |
|---|---|
| 1 Hour | -23.3 ± 120.9 |
| 2 Hour | -20.3 ± 122.3 |
| 4 Hour | -7.0 ± 64.5 |
| 72 Hour | -30.1 ± 77.3 |
Change from baseline in ECG Ventricular Rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.
| beats per minute | Zoliflodacin |
|---|---|
| 1 Hour | 1.4 ± 8.0 |
| 2 Hour | 0.9 ± 6.4 |
| 4 Hour | 0.0 ± 3.6 |
| 72 Hour | 1.8 ± 4.9 |
Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for occult blood were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.
| participants | Zoliflodacin |
|---|---|
| Changes From Baseline for Occult Blood Via Dipstick | 0 |
Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for glucose were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.
| Participants | Zoliflodacin |
|---|---|
| Changes From Baseline for Glucose Via Dipstick | 0 |
Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for protein were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.
| Participants | Zoliflodacin |
|---|---|
| Changes From Baseline for Protein Via Dipstick | 0 |
Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment.
| Participants | Zoliflodacin |
|---|---|
| Occurrence of Unsolicited Treatment-emergent Adverse Events | 8 |
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect.
| Participants | Zoliflodacin |
|---|---|
| Occurrence of Treatment-emergent Serious Adverse Events | 0 |
Collected over Unsolicited Adverse Events and serious adverse events (SAEs) were collected from study product administration to Day 8.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zoliflodacin | 0/8 (0%) | 0/8 (0%) | 8/8 (100%) |
| Event | Zoliflodacin |
|---|---|
| ELECTROCARDIOGRAM QT PROLONGEDInvestigations | 6/8 |
| HEART RATE DECREASEDInvestigations | 4/8 |
| DIARRHOEAGastrointestinal disorders | 1/8 |
| ABDOMINAL PAINGastrointestinal disorders | 1/8 |
| NEUTROPHIL COUNT DECREASEDInvestigations | 1/8 |
| WHITE BLOOD CELL COUNT DECREASEDInvestigations | 1/8 |
| DERMATITIS CONTACTSkin and subcutaneous tissue disorders | 1/8 |
All participants are included in the baseline analysis population.
| Age, Categorical(Participants) | Zoliflodacin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Age, Continuous(years) | Zoliflodacin |
|---|---|
| Mean | 26.0 ± 3.6 |
| Sex: Female, Male(Participants) | Zoliflodacin |
|---|---|
| Female | 4 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Zoliflodacin |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Zoliflodacin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Zoliflodacin |
|---|---|
| United States | 8 |
| Body Mass Index(kg/m2) | Zoliflodacin |
|---|---|
| Mean | 25.50 ± 1.59 |
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Studies of the drug tested here: Zoliflodacin
National Institute of Allergy and Infectious Diseases (NIAID) →