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

Full record on ClinicalTrials.gov

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