Effect of Itraconazole on the Pharmacokinetics of BIIB074

Biogen16 enrolled

Overview

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 \[M16\]).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuropathic Pain

Interventions

BIIB074DRUG

Administered as specified in the treatment arm

ItraconazoleDRUG

200 mg twice daily \[BID\] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Leeds, United Kingdom

Outcomes

Primary Outcomes

Maximum observed concentration (Cmax) of BIIB074

Time frame: Prior to dosing up to 96 hours post dose

Exposure of BIIB074 as measured by area under the concentration-time curve from time zero to infinity (AUCinf)

Time frame: Prior to dosing up to 96 hours post dose

Secondary Outcomes

Terminal elimination half-life (t1/2) of BIIB074

Time frame: 96 hours post dose

Apparent total body clearance (CL/F) of BIIB074

Time frame: 96 hours post dose

Apparent volume of distribution (Vd/F) of BIIB074

Time frame: 96 hours post dose

Area under the concentration-time curve from time zero to time of the last measurable drug concentration (AUC0-t) of BIIB074

Time frame: Prior to dosing up to 96 hours post dose

Time that the maximum observed concentration occurs (Tmax) of BIIB074

Time frame: Prior to dosing up to 96 hours post dose

Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)

Time frame: Up to 25 days

Number of participants with clinically significant vital sign abnormalities

Time frame: Up to 25 days

Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

Time frame: Up to 25 days

Data from ClinicalTrials.gov

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