NCT03385525

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

A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	BIIB074	Administered as specified in the treatment arm
DRUG	Valproic Acid	Administered as specified in the treatment arm

Timeline

• Start date: 2017-09-12
• Primary completion: 2017-10-13
• Completion: 2017-10-13
• First posted: 2017-12-28
• Last updated: 2018-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study