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

Phase 1 Completed 30 enrolled Biogen

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2017-09-12
Primary completion: 2017-10-13
Completion: 2017-10-13

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Valproic Acid	Small molecule	500 mg	Oral
Subject	Vixotrigine	Small molecule	150 mg	Oral

Indications

No indication recorded.