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NCT02071121 · ClinicalTrials.gov registry record · Phase 1
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT02071121: Completed Phase 1 study, sponsored by Biogen.
NCT02071121 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02071121, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG BIIB061
- DRUG 14C-BIIB061
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT02071121 record still lists
NCT02071121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02071121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02071121 about?
NCT02071121 is a clinical study titled "Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect". 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 B...
What is the current status of trial NCT02071121?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2013-12. Estimated completion is 2014-09.
What interventions are being tested in trial NCT02071121?
The interventions under investigation include: Placebo (DRUG), BIIB061 (DRUG), 14C-BIIB061 (DRUG).
Who is sponsoring clinical trial NCT02071121?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02071121's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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