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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy; Trigeminal Neuralgia

Treatments: Drug: Placebo; Drug: BIIB074

Study type: Interventional

Funder types: Industry

Identifiers

NCT02831517

802HV106

2016-000874-39 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Part 1

Experimental group

Description:

48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio

Treatment:

Drug: Placebo

Drug: BIIB074

Part 2

Experimental group

Description:

16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily \[TID\] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily \[BID\] in cohort 5 for 6 days and QD for 1 day

Treatment:

Drug: Placebo

Drug: BIIB074