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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 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03385525
The ClinicalTrials.gov registry entry for NCT03385525 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 2 interventions - of which Valproic Acid is the first listed.
NCT03385525 reports 0 study locations.
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.
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