A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-11

Study Completion Date

2018-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Drug Interactions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIIB074 150 mg and Oral Contraceptive

Participants will receive BIIB074 in tablet form in 150 mg doses every 8 hours on prescription (TID) on days 1-7 and on days 26-32. OC will be taken in tablet form (ethinyl estradiol 30 micrograms and levonorgestrel 150 micrograms) once daily (QD) on days 12-32.

Group Type EXPERIMENTAL

BIIB074

Intervention Type DRUG

BIIB074 is administered as specified in the treatment arm.

OC (ethinyl estradiol and levonorgestrel)

Intervention Type DRUG

OC is administered as specified in the treatment arm.

Interventions

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BIIB074

BIIB074 is administered as specified in the treatment arm.

Intervention Type DRUG

OC (ethinyl estradiol and levonorgestrel)

OC is administered as specified in the treatment arm.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have a body mass index between 18 and 32 kg/m\^2, inclusive.
* Females of childbearing potential must practice effective non-hormonal contraception during the study and be willing and able to continue contraception for 5 weeks after their last dose of study treatment,
* Must be in good health as determined by the Investigator, based on medical history and screening evaluations.

Exclusion Criteria

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* History of, or positive test result at Screening for, human immunodeficiency virus (HIV)
* Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
* Previous intolerance to OC medications
* Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes