Effect of Itraconazole on the Pharmacokinetics of BIIB074
- Registration Number
- NCT02698267
- Lead Sponsor
- Biogen
- 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 \[M16\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BIIB074 BIIB074 Administered orally on Day 1 and Day 11 BIIB074 Itraconazole Administered orally on Day 1 and Day 11
- Primary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) of BIIB074 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) Prior to dosing up to 96 hours post dose
- Secondary Outcome Measures
Name Time Method Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16) Prior to dosing up to 96 hours post dose Number of participants with clinically significant vital sign abnormalities Up to 25 days Time that the maximum observed concentration occurs (Tmax) of BIIB074 Prior to dosing up to 96 hours post dose Terminal elimination half-life (t1/2) of BIIB074 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 Prior to dosing up to 96 hours post dose Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs) Up to 25 days Apparent volume of distribution (Vd/F) of BIIB074 96 hours post dose Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074 Prior to dosing up to 96 hours post dose Effect of CYP3A4 inhibition on the Tmax of CNV2288584 (M16) Prior to dosing up to 96 hours post dose Apparent total body clearance (CL/F) of BIIB074 96 hours post dose Number of participants with clinically significant laboratory assessment abnormalities Up to 25 days Effect of CYP3A4 inhibition on the Cmax of 3 metabolites of BIIB074 Prior to dosing up to 96 hours post dose Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities Up to 25 days Effect of CYP3A4 inhibition on the AUC0-t of CNV2283325 (M14) Prior to dosing up to 96 hours post dose Effect of CYP3A4 inhibition on the AUC0-t of CNV3000497 (M13) Prior to dosing up to 96 hours post dose Effect of CYP3A4 inhibition on the AUC0-t of CNV2288584 (M16) Prior to dosing up to 96 hours post dose Effect of CYP3A4 inhibition on the Tmax of CNV3000497 (M13) Prior to dosing up to 96 hours post dose Effect of CYP3A4 inhibition on the Tmax of CNV2283325 (M14) Prior to dosing up to 96 hours post dose Effect of CYP3A4 inhibition on the t1/2 of CNV3000497 (M13) Prior to dosing up to 96 hours post dose Effect of CYP3A4 inhibition on the t1/2 of CNV2283325 (M14) Prior to dosing up to 96 hours post dose
Trial Locations
- Locations (1)
Research Site
🇬🇧Leeds, United Kingdom