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

NCT ID: NCT03402178

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-21
• Study Completion Date: 2020-02-20

Brief Summary

This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending oral doses of E2082 in healthy Japanese adult and elderly male participants, and to evaluate the safety, tolerability, and PK of multiple ascending oral doses of E2082 in healthy Japanese and Caucasian adult male participants.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

E2082

E2082 will be administered as a solution (0.2 milligram \[mg\]), a 0.5 mg tablet, and a 5 mg tablet. Part A: Cohort 1 participants will receive a single dose of a 0.2 mg E2082 solution, and participants in Cohorts 2 to 4, respectively, will receive a single dose of 0.5 mg, 1 mg, or 2.5 mg E2082 tablets under fasted conditions. Cohort 5 participants will receive a single dose of 5 mg E2082 under fasted conditions, and then they will receive 5 mg E2082 under fed conditions after washout. Participants in Cohorts 6 to 10, respectively, will receive 10 mg (adult participants), 15 mg, 25 mg, 40 mg, or 10 mg (elderly participants) E2082 tablets under fasted conditions. Part B: Participants in Cohorts 1 to 4, respectively, will receive 2.5 mg, 5 mg, 10, or 15 mg tablets once daily for 10 days. E2082 will be administered under fasted conditions on Day 1 and Day 10 and under fed conditions during Day 2 to Day 9.

Group Type: EXPERIMENTAL

E2082

Intervention Type: DRUG

Solution (0.2 mg) or tablet (0.5 mg and 5 mg).

E2082-matched placebo

Matched placebo will be administered as a solution (0.2 mg), a 0.5 mg tablet, and a 5 mg tablet. Part A: Cohort 1 participants will receive a single dose of a 0.2 mg matched placebo solution, and participants in Cohorts 2 to 4, respectively, will receive a single dose of 0.5 mg, 1 mg, or 2.5 mg matched placebo tablets under fasted conditions. Cohort 5 participants will receive a single dose of 5 mg matched placebo under fasted conditions, and then they will receive 5 mg matched placebo under fed conditions after washout. Participants in Cohorts 6 to 10, respectively, will receive 10 mg (adult participants), 15 mg, 25 mg, 40 mg, or 10 mg (elderly participants) matched placebo tablets under fasted conditions. Part B: Participants in Cohorts 1 to 4, respectively, will receive 2.5 mg, 5 mg, 10, or 15 mg matched placebo tablets once daily for 10 days. Matched placebo will be administered under fasted conditions on Day 1 and Day 10 and under fed conditions during Day 2 to Day 9.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution (0.2 mg) or tablet (0.5 mg and 5 mg) matched to E2082.

Interventions

E2082

Solution (0.2 mg) or tablet (0.5 mg and 5 mg).

Intervention Type: DRUG

Placebo

Solution (0.2 mg) or tablet (0.5 mg and 5 mg) matched to E2082.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Participants must meet all of the following criteria to be included in this study:

• Non-smoking, age ≥20 years and <55 years old adult male (Cohorts 1 to 9 of Part A and all cohorts of Part B), or age ≥55 years and ≤85 years old elderly male (only Cohort 10 of Part A) at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.
• Body mass index ≥18 and <30 kilograms per meters squared at Screening

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from this study:

• Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
• Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of E2082, example, hepatectomy, nephrectomy, and digestive organ resection
• Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, electrocardiogram finding, or laboratory test results that require medical treatment at Screening

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eisai Trial Site

Sumida-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

E2082-J081-001

Identifier Type: -

Identifier Source: org_study_id