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The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective of the study is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered twice daily (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: Dose 1 | Experimental | Japanese and non-Japanese participants will receive BIIB104, Dose 1, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10. |
|
| BIIB104: Dose 2 | Experimental | Japanese and non-Japanese participants will receive BIIB104, Dose 2, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10. |
|
| Placebo | Placebo Comparator | Japanese and non-Japanese participants will receive BIIB104-matching placebo, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB104 | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of BIIB104 | Up to Day 11 | |
| Time to Reach Maximum Observed Concentration (Tmax) of BIIB104 | Up to Day 11 | |
| Area Under the Concentration-Time Curve Within a Dosing Interval for Single Dose [AUC(tau,sd)] of BIIB104 | Up to Day 11 | |
| Maximum Observed Concentration at Steady State (Cmax,ss) of BIIB104 | Up to Day 11 | |
| Time to Reach Maximum Observed Concentration at Steady State (Tmax,ss) of BIIB104 | Up to Day 11 | |
| Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State [AUC(tau,ss)] of BIIB104 | Up to Day 11 | |
| Apparent Total Body Clearance (CL/F) of BIIB104 | Up to Day 11 | |
| Apparent Volume of Distribution (Vz/F) of BIIB104 | Up to Day 11 | |
| Elimination Half-Life (t½) of BIIB104 | Up to Day 11 | |
| Accumulation Ratio for Steady State of BIIB104 | Accumulation ratio for steady state is defined as area under the concentration-time curve over a uniform dosing interval tau at steady state divided by area under the concentration-time curve within a dosing interval for single dose [AUC(tau,ss)/AUC(tau,sd)]. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
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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 | Anaheim | California | 92801 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Placebo | Drug | Administered as specified in the treatment arm |
|
| Up to Day 11 |
| Trough Concentration (Ctrough) of BIIB104 | Up to Day 11 |
| Day 1 up to Day 25 |
| Number of Participants with Serious Adverse Events (SAEs) | A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), 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. | From screening up to Day 25 |