Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074

NCT ID: NCT03385525

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-12
• Study Completion Date: 2017-10-13

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 study are to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with the UGT inhibitor valproic acid and to evaluate the effect of the UGT inhibitor valproic acid on the PK of the M13, M14, and M16 metabolites of BIIB074.

Conditions

Drug Interaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIIB074 150 mg and Valproic Acid 500 mg

Participants will receive BIIB074 in tablet form in 150 mg doses. BIIB074 will be taken once daily (QD) on Days 1-16 after an 8-hour fast. Valproic Acid will be given in capsule form in 500 mg doses on prescription (TID) every 8 hours on Days 8-22. The morning dose on Day 16 will be coadministered with BIIB074 following an 8-hour fast.

Group Type: EXPERIMENTAL

BIIB074

Intervention Type: DRUG

Administered as specified in the treatment arm

Valproic Acid

Intervention Type: DRUG

Administered as specified in the treatment arm

Interventions

BIIB074

Administered as specified in the treatment arm

Intervention Type: DRUG

Valproic Acid

Administered as specified in the treatment arm

Intervention Type: DRUG

Other Intervention Names

Depakote, Depakene, Stavzor, and Valproic

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Dallas, Texas, United States

Countries

United States

References

Zhao Y, Kotecha M, Finnigan H, Serenko M, Naik H. Evaluation of the Effect of Uridine Diphosphate-Glucuronosyltransferases (UGT) Inhibition by Valproic Acid on Vixotrigine Pharmacokinetics in Healthy Volunteers. Clin Drug Investig. 2022 Oct;42(10):829-837. doi: 10.1007/s40261-022-01194-y. Epub 2022 Aug 31.

Reference Type: DERIVED

PMID: 36045316 (View on PubMed)

Other Identifiers

802HV109

Identifier Type: -

Identifier Source: org_study_id