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NCT05152485 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT05152485: Completed Phase 1 study, sponsored by Biogen.
NCT05152485 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05152485, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants. The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration.
Interventions
- DRUG BIIB104 Reference Formulation
- DRUG BIIB104 Test Formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-12-15 |
| Est. Completion | 2022-01-31 |
| Phase | Phase 1 |
What the finished NCT05152485 record still lists
NCT05152485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which BIIB104 Reference Formulation is the first listed.
NCT05152485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05152485 about?
NCT05152485 is a clinical study titled "A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants". The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for t...
What is the current status of trial NCT05152485?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2021-12-15. Estimated completion is 2022-01-31.
What interventions are being tested in trial NCT05152485?
The interventions under investigation include: BIIB104 Reference Formulation (DRUG), BIIB104 Test Formulation (DRUG).
Who is sponsoring clinical trial NCT05152485?
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 NCT05152485's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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