Clinical trial NCT02698267: Effect of Itraconazole on the Pharmacokinetics of BIIB074
Official title: An Open-label, Fixed-sequence, Phase 1 Study of the Effect of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of BIIB074 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neuropathic Pain
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 \[M16\]).


Eligibility 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.

Primary outcomes:
measure: Maximum observed concentration (Cmax) of BIIB074
timeFrame: Prior to dosing up to 96 hours post dose
measure: Exposure of BIIB074 as measured by area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: Prior to dosing up to 96 hours post dose
Secondary outcomes:
measure: Terminal elimination half-life (t1/2) of BIIB074
timeFrame: 96 hours post dose
measure: Apparent total body clearance (CL/F) of BIIB074
timeFrame: 96 hours post dose
measure: Apparent volume of distribution (Vd/F) of BIIB074
timeFrame: 96 hours post dose
measure: Area under the concentration-time curve from time zero to time of the last measurable drug concentration (AUC0-t) of BIIB074
timeFrame: Prior to dosing up to 96 hours post dose
measure: Time that the maximum observed concentration occurs (Tmax) of BIIB074
timeFrame: Prior to dosing up to 96 hours post dose
measure: Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 25 days
measure: Number of participants with clinically significant vital sign abnormalities
timeFrame: Up to 25 days
measure: Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
timeFrame: Up to 25 days
measure: Number of participants with clinically significant laboratory assessment abnormalities
timeFrame: Up to 25 days
measure: Effect of CYP3A4 inhibition on the Cmax of 3 metabolites of BIIB074
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the AUC0-t of CNV3000497 (M13)
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the AUC0-t of CNV2283325 (M14)
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the AUC0-t of CNV2288584 (M16)
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the Tmax of CNV3000497 (M13)
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the Tmax of CNV2283325 (M14)
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the Tmax of CNV2288584 (M16)
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the t1/2 of CNV3000497 (M13)
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the t1/2 of CNV2283325 (M14)
timeFrame: Prior to dosing up to 96 hours post dose
measure: Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16)
timeFrame: Prior to dosing up to 96 hours post dose
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: