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drugset / Trial / NCT03402178

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

NCT03402178 ↗

Phase 1 Terminated 118 enrolled Eisai Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Outcome

Outcome not reported

Stopped: “Safety Review”

Drugs

EvaluationDrugModalityDoseRoute
Subject E2082 Unknown 0.2 mg Oral
Subject E2082 Unknown 0.5 mg Oral
Subject E2082 Unknown 1 mg Oral
Subject E2082 Unknown 2.5 mg Oral
Subject E2082 Unknown 5 mg Oral
Subject E2082 Unknown 10 mg Oral
Subject E2082 Unknown 15 mg Oral
Subject E2082 Unknown 25 mg Oral
Subject E2082 Unknown 40 mg Oral

Indications

No indication recorded.