Effect of Itraconazole on the Pharmacokinetics of BIIB074

Biogen

Status and phase: Completed; Phase 1

Conditions: Neuropathic Pain

Treatments: Drug: BIIB074; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02698267

2015-005096-25 (EudraCT Number)

802HV104

Details and patient eligibility

About

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]).

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

BIIB074

Experimental group

Description:

Administered orally on Day 1 and Day 11

Treatment:

Drug: Itraconazole

Drug: BIIB074