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NCT03385525 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03385525: Completed Phase 1 study, sponsored by Biogen.
NCT03385525 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03385525, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of multiple doses of the UGT inhibitor valproic acid on the single-dose pharmacokinetics of BIIB074. The secondary objectives of this study are to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with the UGT inhibitor valproic acid and to evaluate the effect of the UGT inhibitor valproic acid on the PK of the M13, M14, and M16 metabolites of BIIB074.
Interventions
- DRUG Valproic Acid
- DRUG BIIB074
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-09-12 |
| Est. Completion | 2017-10-13 |
| Phase | Phase 1 |
What the finished NCT03385525 record still lists
NCT03385525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Valproic Acid is the first listed.
NCT03385525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03385525 about?
NCT03385525 is a clinical study titled "Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074". The primary objective of this study is to evaluate the effect of multiple doses of the UGT inhibitor valproic acid on the single-dose pharmacokinetics of BIIB074. The secondary objectives of this study are to evaluate the safety and tolerability of BIIB074 when administered alone and when coadminist...
What is the current status of trial NCT03385525?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2017-09-12. Estimated completion is 2017-10-13.
What interventions are being tested in trial NCT03385525?
The interventions under investigation include: Valproic Acid (DRUG), BIIB074 (DRUG).
Who is sponsoring clinical trial NCT03385525?
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 NCT03385525's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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