NCT03454126

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

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	BIIB095	Administered as specified in the treatment arm.
DRUG	Placebo	Administered as specified in the treatment arm.

Timeline

• Start date: 2018-03-29
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2018-03-05
• Last updated: 2019-05-16

Locations

2 sites across 1 country: United Kingdom