A Phase 1 interventional study of ETX0282 and Cefpodoxime proxetil in Healthy Volunteers, sponsored by Entasis Therapeutics. Completed at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by Entasis Therapeutics · Phase 1, Interventional, and Treatment
This research project is being conducted to investigate the safety, tolerability, and pharmacokinetics (PK) of a single ascending dose (SAD) and multiple ascending doses (MAD) of oral ETX0282 when administered alone and in combination with cefpodoxime proxetil in healthy adult participants.
This Phase 1, single-center, double-blind, randomized, placebo-controlled study will be conducted to:
59 studies on the registry are indexed under Enterobacteriaceae Infections; 14 are open to participants now.
This study's enrollment of 99 is close to the median of 99 across 27 interventional studies indexed under Enterobacteriaceae Infections.
Browse Enterobacteriaceae Infections studies →Entasis Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) 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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
Part A of the study will explore the safety, tolerability, and pharmacokinetics (PK) of a single ascending dose (SAD) of oral ETX0282. Participants will be treated with a single oral dose of 100 milligrams (mg) ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4).
Drug: ETX0282 · Drug: Placebo
Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4).
Drug: ETX0282 · Drug: Placebo
Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Participants will be treated with a single oral dose of 400 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4).
Drug: ETX0282 · Drug: Placebo
Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Participants will be treated with a single oral dose of 800 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4).
Drug: ETX0282 · Drug: Placebo
Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Participants will be treated with a single oral dose of 600 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4).
Drug: ETX0282 · Drug: Placebo
Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Elderly participants (aged 65 years or older) will be treated with a single oral dose of 300 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4).
Drug: ETX0282 · Drug: Placebo
Part B of the study will explore the effect of food on oral ETX0282. Participants will be treated with a single oral dose of 100 mg ETX0282 or placebo (Day 1) while fasted and with a single oral dose of 100 mg ETX0282 or placebo (Day 4) with a high-fat meal. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post fed state dose assessments (Day 7).
Drug: ETX0282 · Drug: Placebo
Part C of the study will explore the safety, tolerability, and PK of MAD of oral ETX0282. Part C will be administered in a fed state. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo on the morning of Day 1, and will then be dosed three times a day (TID) beginning on the morning of Day 2 (i.e., 24 hours after the Day 1 dose) through Day 7. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo on the morning of Day 8. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post Day 8 dose assessments (Day 11).
Drug: ETX0282 · Drug: Placebo
Part C of the study will explore the safety, tolerability, and PK of MAD of oral ETX0282. Part C will be administered in a fed state. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo on the morning of Day 1, and will then be dosed TID beginning on the morning of Day 2 (i.e., 24 hours after the Day 1 dose) through Day 7. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo on the morning of Day 8. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post Day 8 dose assessments (Day 11).
Drug: ETX0282 · Drug: Placebo
Part D of the study will explore the safety, tolerability, and PK of oral ETX0282 when administered as a single oral dose in combination with cefpodoxime proxetil tablets to healthy participants in a fed state. Participants will be treated with a single oral dose of 600 mg ETX0282 or placebo in a fed state on Day 1, with a single oral dose of 400 mg cefpodoxime proxetil in a fed state on Day 4, and with a single oral dose of 600 mg ETX0282 or placebo plus a single oral dose of 400 mg cefpodoxime proxetil dosed at the same time in a fed state on Day 7. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post Day 7 dose assessments (Day 10).
Drug: ETX0282 · Drug: Cefpodoxime proxetil · Drug: Placebo
Part B of the study will explore the effect of food on oral ETX0282. Participants will be treated with a single oral dose of 300 mg ETX0282 or placebo (Day 1) while fasted and with a single oral dose of 300 mg ETX0282 or placebo (Day 4) with a high-fat meal. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post fed state dose assessments (Day 7).
Drug: ETX0282 · Drug: Placebo
Part G of the study will explore the tolerability and PK profile of oral ETX0282 when administered either as a single dose (i.e., 300 mg as a single dose) or in 4 equal, divided doses over a 6 hour period (i.e., 75 mg every 2 hours for 4 doses \[a 300 mg total dose\]) when administered in a fasted state. Participants will receive the 2 treatments in a cross-over design according to one of 2 randomized sequences: AB or BA. Treatment A: 0 hours, 4 × 75 mg ETX0282/placebo; 2, 4, and 6 hours, 1 × 75 mg placebo. Treatment B: 0 hours, 1 × 75 mg ETX0282/placebo and 3 × 75 mg placebo; 2, 4, and 6 hours, 1 × 75 mg ETX0282/placebo. Participants will be confined to the Study Unit from Day -1 and discharged following collection of the 24 hours post Day 4 dose assessments (Day 5).
Drug: ETX0282 · Drug: Placebo
Oral Gelatin capsules
Oral tablets
Oral Gelatin capsules
Number of participants with any non-serious adverse event
Time frame: Up to 14 days after the last dose of study drug (Study Day [SD] 210)
Number of participants with any serious adverse event
Time frame: Up to 14 days after the last dose of study drug (SD 210)
Number of participants with an adverse event of the indicated causality and severity
Time frame: Up to 14 days after the last dose of study drug (SD 210)
Part A: Number of participants with abnormal, clinically significant hematology, clinical chemistry, and urinalysis laboratory values at the indicated time points
Time frame: Screening (Day -1) up to Day 15±2 (Follow-up)
Part B: Number of participants with abnormal, clinically significant hematology, clinical chemistry, and urinalysis laboratory values at the indicated time points
Time frame: Screening (Day -1; SD 44) up to Day 18±2 (SD 62±2; Follow-up)
Part C: Number of participants with abnormal, clinically significant hematology, clinical chemistry, and urinalysis laboratory values at the indicated time points
Time frame: Screening (Day -1; SD 91) up to Day 22±2 (SD 113±2; Follow-up)
Part D: Number of participants with abnormal, clinically significant hematology, clinical chemistry, and urinalysis laboratory values at the indicated time points
Time frame: Screening (Day -1; SD 142) up to Day 21±2 (SD 163±2; Follow-up)
Part G: Number of participants with abnormal, clinically significant hematology, clinical chemistry, and urinalysis laboratory values at the indicated time points
Time frame: Screening (Day -1; SD 192) up to Day 18±2 (SD 210±2; Follow-up)
Part A: Number of participants with abnormal, clinically significant vital sign values at the indicated time points
Time frame: Screening (Day -1) up to Day 15±2 (Follow-up)
Part B: Number of participants with abnormal, clinically significant vital sign values at the indicated time points
Time frame: Screening (Day -1; SD 44) up to Day 18±2 (SD 62±2; Follow-up)
Part C: Number of participants with abnormal, clinically significant vital sign values at the indicated time points
Time frame: Screening (Day -1; SD 91) up to Day 22±2 (SD 113±2; Follow-up)
Part D: Number of participants with abnormal, clinically significant vital sign values at the indicated time points
Time frame: Screening (Day -1; SD 142) up to Day 21±2 (SD 163±2; Follow-up)
Part G: Number of participants with abnormal, clinically significant vital sign values at the indicated time points
Time frame: Screening (Day -1; SD 192) up to Day 18±2 (SD 210±2; Follow-up)
Part A: Number of participants with abnormal, clinically significant electrocardiogram values at the indicated time points
Time frame: Screening (Day -1) up to Day 15±2 (Follow-up)
Part B: Number of participants with abnormal, clinically significant electrocardiogram values at the indicated time points
Time frame: Screening (Day -1; SD 44) up to Day 18±2 (SD 62±2; Follow-up)
Part C: Number of participants with abnormal, clinically significant electrocardiogram values at the indicated time points
Time frame: Screening (Day -1; SD 91) up to Day 22±2 (SD 113±2; Follow-up)
Part D: Number of participants with abnormal, clinically significant electrocardiogram values at the indicated time points
Time frame: Screening (Day -1; SD 142) up to Day 21±2 (SD 163±2; Follow-up)
Part G: Number of participants with abnormal, clinically significant electrocardiogram values at the indicated time points
Time frame: Screening (Day -1; SD 192) up to Day 18±2 (SD 210±2; Follow-up)
Part A: Mean peak plasma concentration (Cmax) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean plasma concentration at time t (Ct) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean time to peak plasma concentration (Tmax) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean area under the concentration-time curve from time 0 to 24 hours (AUC0-24) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), and 24 (Day 2) hours postdose
Part A: Mean area under the concentration-time curve from time 0 to the last time point evaluated (AUC0-t) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean area under the concentration-time curve from time 0 and extrapolated to infinity (AUC0-∞) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean elimination rate constant (Kel) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean elimination half-life (t½) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean clearance (CL) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean volume of distribution (Vdss) of ETX0282 and ETX1317 in blood in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean cumulative excretion of unchanged ETX0282 and ETX1317 in urine (Ae) in Cohorts 1 to 5
Time frame: Prior to dosing (-6 to 0 hours; Day 1); 0 to 8 (Day 1), 8 to 24 (Day 2), 24 to 48 (Day 3), and 48 to 72 (Day 4) hours postdose
Part A: Mean urinary clearance (CLR) of ETX0282 and ETX1317 in Cohorts 1 to 5
Time frame: Prior to dosing (-6 to 0 hours; Day 1); 0 to 8 (Day 1), 8 to 24 (Day 2), 24 to 48 (Day 3), and 48 to 72 (Day 4) hours postdose
Part A: Mean fraction of the administered dose of ETX0282 and ETX1317 that is excreted unchanged in the urine (fe) in Cohorts 1 to 5
Time frame: Prior to dosing (-6 to 0 hours; Day 1); 0 to 8 (Day 1), 8 to 24 (Day 2), 24 to 48 (Day 3), and 48 to 72 (Day 4) hours postdose
Part A: Mean dose proportionality of ETX0282 and ETX1317 in Cohorts 1 to 5
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part C: Mean Cmax of ETX0282 and ETX1317 in blood
min, minutes
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean Ct of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean Tmax of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean AUC0-24 of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean AUC0-t of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean AUC0-∞ of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean AUC from time 0 to the end of the dosing period (AUC0-tau) of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean accumulation ratio (R0) of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean Kel of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean t½ of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean CL of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean Vdss of ETX0282 and ETX1317 in blood
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part C: Mean Ae of ETX0282 and ETX1317
Time frame: Days 1-4 and 8-11 (SDs 92-95 and 99-102): prior to dosing (-6 to 0 hours; first and last doses) and at 0-8, 8-24, 24-48, and 48-72 hours post first and last dose
Part C: Mean CLR of ETX0282 and ETX1317
Time frame: Days 1-4 and 8-11 (SDs 92-95 and 99-102): prior to dosing (-6 to 0 hours; first and last doses) and at 0-8, 8-24, 24-48, and 48-72 hours post first and last dose
Part C: Mean fe of ETX0282 and ETX1317
Time frame: Days 1-4 and 8-11 (SDs 92-95 and 99-102): prior to dosing (-6 to 0 hours; first and last doses) and at 0-8, 8-24, 24-48, and 48-72 hours post first and last dose
Part C: Mean dose proportionality of ETX0282 and ETX1317
Time frame: Days 1-3, 5, and 8 (SDs 92-94, 96, and 99): predose (30 min); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours post first dose; at troughs of Days 3, 5, and 8 (SDs 94, 96, and 99); at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post last dose
Part D: Mean Cmax of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Ct of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Tmax of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean AUC0-24 of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose
Part D: Mean AUC0-t of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean AUC0-∞ of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Kel of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean t½ of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean CL of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Vdss of ETX0282 and ETX1317 in blood
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Ae of ETX0282 and ETX1317
Time frame: Days 1-10 (SDs 143-152): prior to dosing (-6 to 0 hours) and at 0-8, 8-24, 24-48, and 48-72 hours postdose
Part D: Mean CLR of ETX0282 and ETX1317
Time frame: Days 1-10 (SDs 143-152): prior to dosing (-6 to 0 hours) and at 0-8, 8-24, 24-48, and 48-72 hours postdose
Part D: Mean fe of ETX0282 and ETX1317
Time frame: Days 1-10 (SDs 143-152): prior to dosing (-6 to 0 hours) and at 0-8, 8-24, 24-48, and 48-72 hours postdose
Part D: Mean dose proportionality of ETX0282 and ETX1317
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Cmax of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Ct of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Tmax of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean AUC0-24 of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose
Part D: Mean AUC0-t of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean AUC0-∞ of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Kel of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean t½ of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean CL of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Vdss of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part D: Mean Ae of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): prior to dosing (-6 to 0 hours) and at 0-8, 8-24, 24-48, and 48-72 hours postdose
Part D: Mean CLR of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): prior to dosing (-6 to 0 hours) and at 0-8, 8-24, 24-48, and 48-72 hours postdose
Part D: Mean fe of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): prior to dosing (-6 to 0 hours) and at 0-8, 8-24, 24-48, and 48-72 hours postdose
Part D: Mean dose proportionality of cefpodoxime proxetil and cefpodoxime following administration of cefpodoxime proxetil as a single oral dose either alone or in combination with ETX0282
Time frame: Days 1-10 (SDs 143-152): predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours postdose
Part G: Mean Cmax of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean Ct of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean Tmax of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean AUC0-24 of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean AUC0-t of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean AUC0-∞ of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean AUC0-tau of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean R0 of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean Kel of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean t½ of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean CL of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean Vdss of ETX0282 and ETX1317 in blood
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean Ae of ETX0282 and ETX1317
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean CLR of ETX0282 and ETX1317
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean fe of ETX0282 and ETX1317
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Part G: Mean dose proportionality of ETX0282 and ETX1317
Time frame: Days 1 and 4 (SDs 193 and 196): 30 minutes predose; 0.25, 0.5, 0.75, 1, 1.5, 2 (predose prior to subsequent dose), 2.5, 3, 4 (predose prior to subsequent dose), 7, 8, 12, and 16 hours postdose. Days 2 and 5 (SDs 194 and 197): 24 hours postdose
Number of elderly participants with any non-serious adverse event
Time frame: Up to 14 days after the last dose of study drug (SD 210)
Number of elderly participants with any serious adverse event
Time frame: Up to 14 days after the last dose of study drug (SD 210)
Number of elderly participants with an adverse event of the indicated causality and severity
Time frame: Up to 14 days after the last dose of study drug (SD 210)
Part A: Number of elderly participants with abnormal, clinically significant hematology, clinical chemistry, and urinalysis laboratory values at the indicated time points
Time frame: Screening (Day -1); Days 2, 3, 4, 7, and 15±2 (Follow-up)
Part A: Number of elderly participants with abnormal, clinically significant vital sign values at the indicated time points
Time frame: Screening (Day -1); Days 2, 3, 4, 7, and 15±2 (Follow-up)
Part A: Number of elderly participants with abnormal, clinically significant electrocardiogram values at the indicated time points
Time frame: Screening (Day -1); Days 1-7; Day 15±2 (Follow-up)
Number of participants who received concomitant medications
Concomitant medications will be coded using the World Health Organization Drug Dictionary. The incidence of participants taking each medication by Anatomical Therapeutic Chemical second and fourth level categories (pharmacological or therapeutic group) will be presented.
Time frame: Up to 14 days after the last dose of study drug (SD 210)
Part A: Mean Cmax of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean Ct of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean Tmax of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean AUC0-24 of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), and 24 (Day 2) hours postdose
Part A: Mean AUC0-t of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean AUC0-∞ of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean Kel of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean t½ of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean CL of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean Vdss of ETX0282 and ETX1317 in blood of elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part A: Mean Ae of ETX0282 and ETX1317 for elderly participants (Cohort 6)
Time frame: Prior to dosing (-6 to 0 hours; Day 1); 0 to 8 (Day 1), 8 to 24 (Day 2), 24 to 48 (Day 3), and 48 to 72 (Day 4) hours postdose
Part A: Mean CLR of ETX0282 and ETX1317 in urine for elderly participants (Cohort 6)
Time frame: Prior to dosing (-6 to 0 hours; Day 1); 0 to 8 (Day 1), 8 to 24 (Day 2), 24 to 48 (Day 3), and 48 to 72 (Day 4) hours postdose
Part A: Mean fe of ETX0282 and ETX1317 for elderly participants (Cohort 6)
Time frame: Prior to dosing (-6 to 0 hours; Day 1); 0 to 8 (Day 1), 8 to 24 (Day 2), 24 to 48 (Day 3), and 48 to 72 (Day 4) hours postdose
Part A: Mean dose proportionality of ETX0282 and ETX1317 for elderly participants (Cohort 6)
Time frame: Predose (0); 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 (Day 1), 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours postdose
Part B: Mean Cmax of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Part B: Mean Ct of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Part B: Mean Tmax of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Part B: Mean AUC0-24 of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, and 24 hours postdose
Part B: Mean AUC0-t of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Part B: Mean AUC0-∞ of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Part B: Mean Kel of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Part B: Mean t½ of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Part B: Mean CL of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Part B: Mean Vdss of ETX0282 and ETX1317 in blood
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Part B: Mean Ae of ETX0282 and ETX1317
Time frame: Days 1-7 (SDs 45-51): prior to dosing (-6 to 0 hours) and at 0-8, 8-24, 24-48, and 48-72 hours postdose
Part B: Mean CLR of ETX0282 and ETX1317
Time frame: Days 1-7 (SDs 45-51): prior to dosing (-6 to 0 hours) and at 0-8, 8-24, 24-48, and 48-72 hours postdose
Part B: Mean fe of ETX0282 and ETX1317
Time frame: Days 1-7 (SDs 45-51): prior to dosing (-6 to 0 hours) and at 0-8, 8-24, 24-48, and 48-72 hours postdose
Part B: Mean dose proportionality of ETX0282 and ETX1317
Time frame: Days 1-7 (SDs 45-51): predose (0), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Ran from Mar 2018 to primary completion in Sep 2019, 17 months.
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