A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BIIB104: Dose 1 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. |
Drug: BIIB104
Administered as specified in the treatment arm
|
| Experimental: BIIB104: Dose 2 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. |
Drug: BIIB104
Administered as specified in the treatment arm
|
| Placebo Comparator: Placebo 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. |
Drug: Placebo
Administered as specified in the treatment arm
|
Outcome Measures
Primary Outcome Measures
- 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 [Up to Day 11]
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)].
- Trough Concentration (Ctrough) of BIIB104 [Up to Day 11]
Secondary Outcome Measures
- Number of Participants with Adverse Events (AEs) [Day 1 up to Day 25]
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.
- Number of Participants with Serious Adverse Events (SAEs) [From screening up to Day 25]
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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Have a body mass index between 18 and 30 kilograms per meter square (kg/m^2), inclusive, and total body weight >50 kilograms (kg) [110 pounds (lb)].
-
For Japanese participants, was born in Japan, and biological parents and grandparents were of Japanese origin.
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For Japanese participants, if living outside Japan for more than 5 years, must not have significantly modified diet since leaving Japan.
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Non-Japanese participants must have a screening weight within ±20% of the mean value for Japanese participants.
Key Exclusion Criteria:
-
Participation in other studies involving treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization and/or during study participation.
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History of severe allergic or anaphylactic reactions, systemic hypersensitivity reaction to BIIB104, or any allergic reactions that in the opinion of the investigator are likely to be exacerbated by any component of the study treatment.
-
History of seizures or a condition with risk of seizures.
-
History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
-
Chronic, recurrent, or serious infection, as determined by the investigator, within 6 months prior to screening or between screening and Day 1.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Anaheim | California | United States | 92801 |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 263HV108