drugset / Trial / NCT02698267

Effect of Itraconazole on the Pharmacokinetics of BIIB074

NCT02698267

Phase 1 Completed 16 enrolled Biogen
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4 inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study are to assess the safety and tolerability of BIIB074 when co-administered with a strong CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of BIIB074 (CNV3000497 \[M13\], CNV2283325 \[M14\], and CNV2288584 \[M16\]).

Timeline

Start
2016-02
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Vixotrigine Small molecule Oral
Background Itraconazole Small molecule 200 mg Oral

Indications