drugset / Trial / NCT02698267
Effect of Itraconazole on the Pharmacokinetics of BIIB074
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vixotrigine | Small molecule | — | Oral |
| Background | Itraconazole | Small molecule | 200 mg | Oral |