Neuropathic Pain
Conditions
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 \[M16\]).
Interventions
DRUGBIIB074
Administered as specified in the treatment arm
DRUGItraconazole
200 mg twice daily \[BID\] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Apparent volume of distribution (Vd/F) 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 |
| Time that the maximum observed concentration occurs (Tmax) 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 |
| Number of participants with clinically significant vital sign abnormalities | Up to 25 days |
| Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities | Up to 25 days |
| 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 |
| Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074 | Prior to dosing up to 96 hours post dose |
| Terminal elimination half-life (t1/2) of BIIB074 | 96 hours post dose |
| 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 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 Tmax of CNV2288584 (M16) | 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 |
| Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16) | 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 |
| Apparent total body clearance (CL/F) of BIIB074 | 96 hours post dose |
Countries
United Kingdom
Outcome results
None listed