Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 36 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03324685
The ClinicalTrials.gov registry entry for NCT03324685 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 BIIB074 is the first listed.
NCT03324685 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.