Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E6742 in Healthy Adult Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2017-10-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study E6742-A001-001 is a randomized, double-blind, placebo-controlled, single ascending dose study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending oral doses of E6742 in healthy adult participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Safety and Tolerability of E6742 in Japanese Healthy Adult Participants

NCT04683185

Healthy Volunteers

COMPLETED PHASE1

Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730

NCT03054194

Healthy Participants

COMPLETED PHASE1

A Study To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Participants

NCT05745207

Healthy Volunteers

COMPLETED PHASE1

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy Participants

NCT03451890

Healthy Participants

COMPLETED PHASE1

Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male Subjects

NCT03402178

Healthy Participants

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1: 10 mg E6742

Participants will receive 10 milligrams (mg) E6742 as a single oral dose in the fasted state.

Group Type EXPERIMENTAL

E6742

Intervention Type DRUG

gelatin capsules

Cohort 1: Matching placebo

Participants will receive a single oral dose of placebo matching E6742 in the fasted state.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gelatin capsules

Cohort 2: 25 mg E6742

Participants will receive 25 mg E6742 as a single oral dose in the fasted state.

Group Type EXPERIMENTAL

E6742

Intervention Type DRUG

gelatin capsules

Cohort 2: Matching placebo

Participants will receive a single oral dose of placebo matching E6742 in the fasted state.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gelatin capsules

Cohort 3: 50 mg E6742

Participants will receive 50 mg E6742 as a single oral dose in the fasted state.

Group Type EXPERIMENTAL

E6742

Intervention Type DRUG

gelatin capsules

Cohort 3: Matching placebo

Participants will receive a single oral dose of placebo matching E6742 in the fasted state.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gelatin capsules

Cohort 4: 100 mg E6742

Participants will receive 100 mg E6742 as a single oral dose in the fasted state. Participants will then receive the same single oral dose of E6742 again in the fed state after a washout interval (at least 7 days or 5 half-lives of E6742, whichever is longer) for the evaluation of food effect.

Group Type EXPERIMENTAL

E6742

Intervention Type DRUG

gelatin capsules

Cohort 4: Matching placebo

Participants will receive a single oral dose of placebo matching E6742 in the fasted state. Participants will then receive the same single oral dose of placebo again in the fed state after a washout interval (at least 7 days ) for the evaluation of food effect.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gelatin capsules

Cohort 5: 200 mg E6742

Participants will receive 200 mg E6742 as a single oral dose in the fasted state.

Group Type EXPERIMENTAL

E6742

Intervention Type DRUG

gelatin capsules

Cohort 5: Matching placebo

Participants will receive a single oral dose of placebo matching E6742 in the fasted state.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gelatin capsules

Cohort 6: 400 mg E6742

Participants will receive 400 mg E6742 as a single oral dose in the fasted state.

Group Type EXPERIMENTAL

E6742

Intervention Type DRUG

gelatin capsules

Cohort 6: Matching placebo

Participants will receive a single oral dose of placebo matching E6742 in the fasted state.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gelatin capsules

Cohort 7: 800 mg E6742

Participants will receive 800 mg E6742 as a single oral dose in the fasted state.

Group Type EXPERIMENTAL

E6742

Intervention Type DRUG

gelatin capsules

Cohort 7: Matching placebo

Participants will receive a single oral dose of placebo matching E6742 in the fasted state.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gelatin capsules

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

E6742

gelatin capsules

Intervention Type DRUG

Placebo

gelatin capsules

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Nonsmoking, male or female, age ≥18 years and ≤45 years old at the time of informed consent
* Body mass index (BMI) ≥18 and \<32 kilograms per meters squared (kg/m2) at Screening

Exclusion Criteria

* Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] or human chorionic gonadotropin \[hCG\] test with a minimum sensitivity of 25 International Units per Liter \[IU/L\] or equivalent units of β-hCG \[or hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
* Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.
* Any history of gastrointestinal surgery that may affect pharmacokinetic (PK) profiles of E6742 (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening
* A prolonged QTcF interval (QTcF \>450 ms) demonstrated on ECG at Screening or Baseline
* Persistent systolic blood pressure \>130 mmHg or diastolic blood pressure \>85 mmHg diastolic at Screening or Baseline Heart rate less than 50 or more than 100 beats/min at Screening or Baseline
* Known history of prolonged QT/QTc interval
* Left bundle branch block
* Known history of myocardial infarction or active ischemic heart disease
* Known history of clinically significant arrhythmia or uncontrolled arrhythmia
* Known history of clinically significant drug allergy at Screening
* Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
* Known to be human immunodeficiency virus (HIV) positive at Screening
* Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
* History of drug or alcohol dependency or abuse within the 2 years prior to Screening, or those who have a positive urine drug and alcohol test at Screening or Baseline
* Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
* Use of prescription drugs within 4 weeks before dosing
* Intake of over-the-counter (OTC) medications within 2 weeks before dosing
* Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) before informed consent
* Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes