A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants

January 13, 2020 updated by: Entasis Therapeutics

A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ETX0282 Administered in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Healthy Volunteers

Intervention / Treatment

Detailed Description

This Phase 1, single-center, double-blind, randomized, placebo-controlled study will be conducted to:

Determine the safety and tolerability of oral ETX0282 when administered as a SAD and MAD to healthy participants;
Determine the safety and tolerability of oral ETX0282 when administered as a single oral dose in combination with cefpodoxime proxetil to healthy participants;
Characterize the PK in plasma and in urine of ETX0282 and ETX1317 following administration of single and multiple oral doses of ETX0282 in healthy participants; and
Determine the PK profile in plasma and in urine of ETX0282 and ETX1317 and of cefpodoxime proxetil and cefpodoxime following administration of single oral doses of ETX0282 and cefpodoxime proxetil alone and when ETX0282 is co-administered with cefpodoxime proxetil at the same time as single oral doses in healthy participants.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - Nucleus Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Aged 18 to 55 years (inclusive) for all participants except for those in Cohort 6 (in Part A); for Cohort 6, only participants aged ≥ 65 years will be enrolled.
Be in general good health without clinically significant medical history
Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations
Body mass index (BMI) ≥18.0 kilograms per meters squared (kg/m^2) and ≤32.0 kg/m^2
Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the Principal Investigator decides that out-of-range values are not clinically significant
Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus at Screening; and drugs of abuse, alcohol predose on Day -1
Female participants must be of non-childbearing potential (postmenopausal or with evidence of tubal ligation) or using a medically acceptable (highly effective method) contraceptive regimen and must have a negative pregnancy test at Screening (serum) and on Day -1 (urine) prior to study drug dosing. Male participants must be surgically sterile or using a medically acceptable contraceptive regimen. Men should not donate sperm during the study or for 90 days after the final dose of study medication.

Exclusion Criteria:

History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antimicrobial (e.g., penicillin or cephalosporin)
History of hypersensitivity or severe allergic reaction of any type to medications, bee stings, food, or environmental factors. A severe allergic reaction is defined as any of the following: anaphylaxis, urticaria, or angioedema.
Use of prescription or over-the-counter medications within 7 days of investigational product administration, with the exception of contraceptive medications, paracetamol, oral non-steroidal anti-inflammatory agents, topical over-the-counter preparations, and routine vitamins (if they do not exceed an intake of 20 to 600 times the recommended daily dose), unless agreed as non-clinically relevant by the Principal Investigator and Sponsor
Participation in an investigational drug or device study within 30 days before study drug dosing, i.e., there were at least 30 days between the last dose in a prior study and dose administration in this study
Current smoker or difficulty abstaining from smoking for the duration of study confinement
History of major organ dysfunction
Infection or any serious underlying medical condition that would impair the participant from receiving study drug
History of excessive alcohol intake (more than 4 standard drinks daily, on average) or use of recreational drugs within the last 3 months
Standard donation of blood within 30 days of the study
Concomitant disease or condition, including laboratory abnormality, which could interfere with the conduct of the study or which would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
Anticipated need for surgery or hospitalization during the study
Surgery within 30 days before study enrolment
Unwillingness or inability to comply with the study protocol for any other reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (SAD): Cohort 1, 100 mg ETX0282/Placebo 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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part A (SAD): Cohort 2, 200 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part A (SAD): Cohort 3, 400 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part A (SAD): Cohort 4, 800 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part A (SAD): Cohort 5, 600 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part A (SAD): Cohort 6 (Elderly), 300 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part B (Food Effect): Cohort 7, 100 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part C (MAD): Cohort 9, 200 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part C (MAD): Cohort 10, 200 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part D: Cohort 12, ETX0282/Placebo plus Cefpodoxime Proxetil 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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules Drug: Cefpodoxime proxetil Oral tablets
Experimental: Part B (Food Effect): Cohort 14, 300 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules
Experimental: Part G: Cohort 17, 300 mg ETX0282/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 Oral Gelatin capsules Drug: Placebo Oral Gelatin capsules

What is the study measuring?

Primary Outcome Measures

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entasis Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2018

Primary Completion (Actual)

September 11, 2019

Study Completion (Actual)

September 11, 2019

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CS0282-2017-0001
1010452 (Other Identifier: INC Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Measure Description	Time Frame
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)		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)		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)		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)		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)		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)		Screening (Day -1); Days 1-7; Day 15±2 (Follow-up)
Number of participants who received concomitant medications Time Frame: Up to 14 days after the last dose of study drug (SD 210)	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.	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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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		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

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants

A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ETX0282 Administered in Healthy Subjects

Study Overview

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Intervention / Treatment

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Secondary Outcome Measures

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