NCT02698267

Effect of Itraconazole on the Pharmacokinetics of BIIB074

An Open-label, Fixed-sequence, Phase 1 Study of the Effect of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of BIIB074 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 \[M16\]).

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	BIIB074	Administered as specified in the treatment arm
DRUG	Itraconazole	200 mg twice daily \[BID\] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-03-03
• Last updated: 2016-06-09

Locations

1 site across 1 country: United Kingdom