PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants. The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biogen

Criteria

Key Inclusion Criteria:

• Japanese or Caucasian.

• Japanese participants must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.

• Must have a body mass index between 18 and 30 kg/m2, inclusive.

Key Exclusion Criteria:

• Previous exposure to BIIB074, with the exception that Japanese participants who complete Part 1.

• Use of any oral, injected, or implanted hormonal method of contraception that contains ethinyl estradiol within 28 days of Day -1 and an unwillingness to refrain from product use during study participation.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.