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NCT03324685 · ClinicalTrials.gov registry record · Phase 1
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03324685: Completed Phase 1 study, sponsored by Biogen.
NCT03324685 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
NCT03324685, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of multiple doses of BIIB074 on the pharmacokinetics(PK) of an OC regimen (ethinyl estradiol and levonorgestrel) at steady state. The secondary objective of this study is to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with a UGT-inducing OC regimen containing ethinyl estradiol and levonorgestrel and to evaluate the effect of a UGT-inducing OC regimen (ethinyl estradiol and levonorgestrel) on the PK of the M13, M14, and M16 metabolites of BIIB074.
Interventions
- DRUG BIIB074
- DRUG OC (ethinyl estradiol and levonorgestrel)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-11-11 |
| Est. Completion | 2018-03-15 |
| Phase | Phase 1 |
What the finished NCT03324685 record still lists
NCT03324685 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 BIIB074 is the first listed.
NCT03324685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03324685 about?
NCT03324685 is a clinical study titled "A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen". The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of multiple doses of BIIB0...
What is the current status of trial NCT03324685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2017-11-11. Estimated completion is 2018-03-15.
What interventions are being tested in trial NCT03324685?
The interventions under investigation include: BIIB074 (DRUG), OC (ethinyl estradiol and levonorgestrel) (DRUG).
Who is sponsoring clinical trial NCT03324685?
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 NCT03324685'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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