drugset / Trial / NCT04079101

Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

NCT04079101

Phase 1 Completed 31 enrolled Biogen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.

Timeline

Start
2019-10-02
Primary completion
2019-12-27
Completion
2019-12-27

Drugs

EvaluationDrugModalityDoseRoute
Subject PESAMPATOR Small molecule 0.15 mg Oral
Subject PESAMPATOR Small molecule 0.5 mg Oral

Indications

No indication recorded.