Status:
COMPLETED
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 multi...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04079101
Start Date
October 2 2019
End Date
December 27 2019
Last Update
March 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Long Beach, California, United States, 90806