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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000874-39 | EudraCT Number |
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The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants. The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | 48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio |
|
| Part 2 | Experimental | 16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily [TID] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily [BID] in cohort 5 for 6 days and QD for 1 day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB074 | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax ) | 15 minutes prior to dosing up to 96 hours post dose | |
| Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax) | 15 minutes prior to dosing up to 96 hours post dose | |
| Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf) | 15 minutes prior to dosing up to 96 hours post dose | |
| Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t) | 15 minutes prior to dosing up to 96 hours post dose | |
| Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2) | 15 minutes prior to dosing up to 96 hours post dose | |
| Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F) | 15 minutes prior to dosing up to 96 hours post dose | |
| Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F) | 15 minutes prior to dosing up to 96 hours post dose | |
| Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC) | 15 minutes prior to dosing up to 96 hours post dose | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 2 weeks post Part 2 of the Treatment Period | |
| Number of participants with clinically significant laboratory assessment abnormalities | Up to 2 weeks post Part 2 of the Treatment Period |
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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 |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| C000592131 | vixotrigine |
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| Placebo | Drug | Matched Placebo |
|
| Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax |
| 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7 |
| Part 2: PK of BIIB074 repeated oral dose as assessed by tmax | 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7 |
| Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau) | 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7 |
| Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough) | 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7 |
| Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2 | 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7 |
| Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F) | 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7 |
| Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F) | 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7 |
| Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac) | 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7 |
| Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC | 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7 |
| Number of participants with clinically significant vital sign abnormalities | Up to 2 weeks post Part 2 of the Treatment Period |
| Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities | Up to 2 weeks post Part 2 of the Treatment Period |
| Number of participants with clinically significant physical examinations abnormalities | Up to 2 weeks post Part 2 of the Treatment Period |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |