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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BIIB104; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04079101

263HV106

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 3 patient groups

BIIB104 0.15 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB104

BIIB104 0.5 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB104

Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo