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NCT06640933 · ClinicalTrials.gov registry record · Phase 1
A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy Participants
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT06640933: Completed Phase 1 study, sponsored by Biogen.
NCT06640933 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06640933, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food. One new form of BIIB091 is an "extended release" tablet, also known as "ER." This form helps release BIIB091 slowly and consistently, helping to keep steady drug levels in the body for longer. The other new form is a "gastro-retentive" tablet, also known as "GR." This form has a special coating that swells and allows BIIB091 to stay in the stomach longer. For both GR and ER tablets, there are also "slow" and "fast" forms that change how quickly BIIB091 is released into the body. But, eating food with these tablets may affect how much BIIB091 is in the body. The main objective of this study is to learn how 2 new forms of BIIB091, which are released into the body at different rates, are processed in the body. Researchers also want to learn how these new forms compare to the "immediate release" tablet, also known as "IR". This form delivers BIIB091 immediately into the body. The main question researchers want to answer in this study is: * How does the body process different tablet forms of BIIB091 with or without food? Researchers will also learn more about: * How the body processes the 2 new tablet forms of BIIB091 with food compared to the IR tablet form with food * How the body processes the ER tablet form of BIIB091 with food compared to without food * Any medical problems the participants have during the study * Any changes in the participants' overall health during the study This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 22 days, after which eligible participants will check into their study research center. * Participants will be randomly assigned to 1 of 6 groups. In each group, the participants will take the below tablet forms, but in different orders: * Immediate-Release (IR) * Gastro-Retentive slow (GR-slow) * Gastro-Retentive fast (
Interventions
- DRUG BIIB091
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-10-16 |
| Est. Completion | 2025-02-07 |
| Phase | Phase 1 |
What the finished NCT06640933 record still lists
NCT06640933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which BIIB091 is the first listed.
NCT06640933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06640933 about?
NCT06640933 is a clinical study titled "A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy Participants". In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food. One new form of BIIB091 is an "extended release" tablet, also known as "ER." This form helps release BIIB091 slowly and consistently, helping to keep steady drug levels in the b...
What is the current status of trial NCT06640933?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2024-10-16. Estimated completion is 2025-02-07.
What interventions are being tested in trial NCT06640933?
The interventions under investigation include: BIIB091 (DRUG).
Who is sponsoring clinical trial NCT06640933?
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 NCT06640933's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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