drugset / Trial / NCT02071121
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2013-12
- Primary completion
- 2014-09
- Completion
- 2014-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 14C-BIIB061 | Unknown | 4 ug | Intravenous |
| Subject | BIIB061 | Unknown | 3 mg | Oral |
| Subject | BIIB061 | Unknown | 10 mg | Oral |
| Subject | BIIB061 | Unknown | 30 mg | Oral |
| Subject | BIIB061 | Unknown | 60 mg | Oral |
| Subject | BIIB061 | Unknown | 100 mg | Oral |
Indications
No indication recorded.