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The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB104 0.15 mg | Experimental | Participants will receive multiple oral doses of BIIB104 0.15 mg capsules twice daily (BID) for 9 days, with an additional dose occurring in the morning on Day 10. |
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| BIIB104 0.5 mg | Experimental | Participants will receive multiple oral doses of BIIB104 0.5 mg capsules BID for 9 days, with an additional dose occurring in the morning on Day 10. |
|
| Placebo | Experimental | Participants will receive multiple oral doses of placebo-matched BIIB104 capsules BID for 9 days, with an additional dose occurring in the morning on Day 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB104 | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 | |
| Time to Reach Maximum Observed Concentration of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 | |
| Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau) of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 | |
| Maximum Observed Concentration at Steady State of BIIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 | |
| Time to Reach Maximum Observed Concentration at Steady State of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 | |
| Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 | |
| Apparent Total Body Clearance of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. | Baseline (Day 1) up to Day 14 |
| Number of Participants With Serious Adverse Events (SAEs) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol specific 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 | Long Beach | California | 90806 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
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| ID | Term |
|---|---|
| C000600968 | PF-04958242 |
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Double-blind
| Placebo | Drug | Administered as specified in the treatment arm. |
|
| Apparent Volume of Distribution of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 |
| Elimination Half-Life of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 |
| Accumulation Ratio at Steady State of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 |
| Trough Concentration of BIIB104 | pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11 |
An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. |
| Screening up to Day 14 |