A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen

Completed · Phase 1

Conditions studied: Drug Interactions

In brief

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.

Key facts

Study ID
NCT03324685
Run by
Biogen
People needed
36
Starts
2017-11-11
Expected to finish
2018-03-15
Last updated by the study team
2018-09-25

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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