Status:
COMPLETED
Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074
Lead Sponsor:
Biogen
Conditions:
Drug Interaction
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the effect of multiple doses of the UGT inhibitor valproic acid on the single-dose pharmacokinetics of BIIB074. The secondary objectives of this stud...
Eligibility Criteria
Inclusion
- Key
- Must have a body mass index between 18 and 32 kg/m\^2, inclusive.
- Must be male, postmenopausal female, or surgically sterile female
- 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 (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator
- Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV)
- Treatment with any prescription or over-the-counter oral medication (excluding acetaminophen) within 14 days prior to Day -1 and an unwillingness or inability to refrain from this treatment during study participation, unless specifically permitted elsewhere within this protocol.
- Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
September 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03385525
Start Date
September 12 2017
End Date
October 13 2017
Last Update
April 20 2018
Active Locations (1)
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1
Research Site
Dallas, Texas, United States, 75247