Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02071121
- Run by
- Biogen
- People needed
- 39
- Starts
- 2013-12-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2015-02-02
Who can join
Age: 20 and older, up to 55. Sex: any. Healthy volunteers: accepted.
Where it is running
- Research Site — Evansville, Indiana, United States
- Research Site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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