Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB061 | Experimental | Single oral dose of 30 mg BIIB061 of the new formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB061 | Drug | Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf) | Day 1-4, 6, 10, 14, 21 | |
| PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast) | Day 1-4, 6, 10, 14, 21 | |
| PK parameter - maximum observed concentration (Cmax) | Day 1-4, 6, 10, 14, 21 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter - Time to reach maximum observed concentration (Tmax) | Day 1-4, 6, 10, 14, 21 | |
| PK parameter - half-life (t1/2) | Day 1-4, 6, 10, 14, 21 | |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Madison | Wisconsin | 53704 | United States |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 21 days |
| Assessment of changes from baseline in Clinical laboratory parameters | Up to 21 days |
| Assessment of clinically relevant abnormalities in Vital signs | Up to 21 days |
| Assessment of physical examinations | Up to 21 days |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |