Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 39 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02071121
The ClinicalTrials.gov registry entry for NCT02071121 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02071121 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.