A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: BIIB104

Study type: Interventional

Funder types: Industry

Identifiers

NCT05148481

263HV108

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.
• 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:

• 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.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

31 participants in 3 patient groups, including a placebo group

BIIB104: Dose 1

Experimental group

Description:

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.

Treatment:

Drug: BIIB104

BIIB104: Dose 2

Experimental group

Description:

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.

Treatment:

Drug: BIIB104

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo