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The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Treatment sub groups A and B |
|
| Cohort 2 | Experimental | Treatment sub groups C and D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB074 Treatment A | Drug | Lower dose RCF fasted |
| |
| BIIB074 Treatment B |
| Measure | Description | Time Frame |
|---|---|---|
| PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax) | Day 1, 2, 3, 8, 9, 10 | |
| PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast) | Day 1, 2, 3, 8, 9, 10 | |
| PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞) | Day 1, 2, 3, 8, 9, 10 | |
| PK of BIIB074 DCF as assessed by Cmax | Day 1, 2, 3, 8, 9, 10 | |
| PK of BIIB074 DCF as assessed by AUClast | Day 1, 2, 3, 8, 9, 10 | |
| PK of BIIB074 DCF as assessed by AUC∞ | Day 1, 2, 3, 8, 9, 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 18 | |
| Number of participants with clinically significant laboratory assessment abnormalities | Up to Day 10 |
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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 | Daytona Beach | Florida | 32117 | United States |
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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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| Drug |
Lower dose DCF fasted |
|
| BIIB074 Treatment C | Drug | Higher dose DCF fasted |
|
| BIIB074 Treatment D | Drug | Higher dose DCF fed |
|
| Number of participants with clinically significant vital sign abnormalities | Up to Day 10 |
| Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities | Up to Day 10 |
| Number of participants with clinically significant physical examinations abnormalities | Up to Day 10 |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |