drugset
drugset / Trial / NCT03454126

Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants

NCT03454126 ↗

Phase 1 Completed 80 enrolled Biogen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to evaluate the safety and tolerability of single- and multiple-ascending oral doses of BIIB095 in healthy participants. The secondary objectives are to characterize the single- and multiple-oral-dose PK of BIIB095 in healthy participants and to investigate the effect of food on the single-oral-dose PK of BIIB095 in healthy participants.

Timeline

Start
2018-03-29
Primary completion
2019-04-30
Completion
2019-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BIIB095 Small molecule 5 mg Oral
Subject BIIB095 Small molecule 25 mg Oral
Subject BIIB095 Small molecule 50 mg Oral
Subject BIIB095 Small molecule 100 mg Oral
Subject BIIB095 Small molecule 200 mg Oral
Subject BIIB095 Small molecule 300 mg Oral
Subject BIIB095 Small molecule 400 mg Oral
Subject BIIB095 Small molecule 600 mg Oral

Indications

No indication recorded.