NCT02071121

Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect

A Randomized, Double-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of single doses of BIIB061 administered to healthy adult volunteers. Secondary objectives in this study population are to determine the single-dose pharmacokinetic (PK) profile and the absolute bioavailability (Fabs) of BIIB061 and to determine the effects of food intake (high-fat, high-calorie meal) on BIIB061 PK and safety.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BIIB061	BIIB061 capsules for oral administration
DRUG	Placebo	BIIB061 matching placebo capsules
DRUG	14C-BIIB061	Radiolabeled containing 14C-BIIB061 ≤ 500 nCi.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-02-25
• Last updated: 2015-02-02

Locations

2 sites across 1 country: United States