Overview

Effect of Itraconazole on the Pharmacokinetics of BIIB074

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
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]).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Biogen
Treatments:
Hydroxyitraconazole
Itraconazole
Criteria
Key Inclusion Criteria:

- Body mass index of 18 to 29 kg/m2, inclusive, with body weight ≥50 kg for males and
≥45 kg for females.

- Male or postmenopausal or surgically sterile females.

- Must be in good health as determined by the Investigator (or designee), based on
medical history and screening evaluations.

Key Exclusion Criteria:

- Females of childbearing potential.

- Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make
the subject unsuitable for enrollment.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.