NCT03324685

A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen

A Phase 1 Study to Evaluate the Pharmacokinetic Interaction Potential Between BIIB074 and an Oral Contraceptive Regimen in Healthy Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Biogen · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	BIIB074	BIIB074 is administered as specified in the treatment arm.
DRUG	OC (ethinyl estradiol and levonorgestrel)	OC is administered as specified in the treatment arm.

Timeline

• Start date: 2017-11-11
• Primary completion: 2018-03-15
• Completion: 2018-03-15
• First posted: 2017-10-30
• Last updated: 2018-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study