Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: BIIB104
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: For Japanese participants, was born in Japan, and biological parents and grandparents were of Japanese origin. For Japanese participants, if living outside Japan for more than 5 years, must not have significantly modified diet since leaving Japan. Non-Japanese participants must have a screening weight within ±20% of the mean value for Japanese participants. Key Exclusion Criteria: Suicide attempt within the last 2 years. Participants who, in the Investigator's judgment, pose a significant suicide risk or who have suicidal ideation associated with actual intent and a method or plan in the past 6 months (i.e., Yes answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale) will be excluded from the study. Note: Other protocol specific inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIB104 0.15 mg<br>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. | Drug: BIIB104<br>* Administered as specified in the treatment arm.<br>* Other names: PF-04958242;|
| Experimental: BIIB104 0.5 mg<br>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. | Drug: BIIB104<br>* Administered as specified in the treatment arm.<br>* Other names: PF-04958242;|
| Experimental: Placebo<br>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. | Drug: Placebo<br>* Administered as specified in the treatment arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |