Clinical trial NCT04079101: Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Concentration of BIIB104
timeFrame: 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: Time to Reach Maximum Observed Concentration of BIIB104
timeFrame: 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: Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau) of BIIB104
timeFrame: 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: Maximum Observed Concentration at Steady State of BIIIB104
timeFrame: 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: Time to Reach Maximum Observed Concentration at Steady State of BIIB104
timeFrame: 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: Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State of BIIB104
timeFrame: 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: Apparent Total Body Clearance of BIIB104
timeFrame: 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: Apparent Volume of Distribution of BIIB104
timeFrame: 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: Elimination Half-Life of BIIB104
timeFrame: 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: Accumulation Ratio at Steady State of BIIB104
timeFrame: 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: Trough Concentration of BIIB104
timeFrame: 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 outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline (Day 1) up to Day 14
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Screening up to Day 14
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Research Site
state: California
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: