Status:
COMPLETED
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
Lead Sponsor:
Biogen
Conditions:
Drug Interactions
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
- NOTE:Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
November 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03324685
Start Date
November 11 2017
End Date
March 15 2018
Last Update
September 25 2018
Active Locations (1)
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1
Research Site
Daytona Beach, Florida, United States, 32117