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

NCT03402178 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-06-30

No results posted yet for this study

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

Interventions

DRUG

E2082

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2020-02-20
Completion
2020-02-20

Countries

  • Japan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03402178 on ClinicalTrials.gov