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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005096-25 | EudraCT Number |
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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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB074 | Experimental | Administered orally on Day 1 and Day 11 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB074 | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal elimination half-life (t1/2) of BIIB074 | 96 hours post dose | |
| Apparent total body clearance (CL/F) of BIIB074 | 96 hours post dose | |
| Apparent volume of distribution (Vd/F) of BIIB074 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leeds | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C000592131 | vixotrigine |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | 200 mg twice daily [BID] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive |
|
|
| 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 |
| 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 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 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010879 |
| Piperazines |