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

Phase 1CompletedNCT02831517

Biogen64 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

64

Conditions

Healthy Trigeminal Neuralgia

Interventions

Administered as specified in the treatment arm

Matched Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Leeds, United Kingdom

Outcomes

Primary Outcomes

Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )

Time frame: 15 minutes prior to dosing up to 96 hours post dose

Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)

Time frame: 15 minutes prior to dosing up to 96 hours post dose

Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)

Time frame: 15 minutes prior to dosing up to 96 hours post dose

Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t)

Time frame: 15 minutes prior to dosing up to 96 hours post dose

Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)

Time frame: 15 minutes prior to dosing up to 96 hours post dose

Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)

Time frame: 15 minutes prior to dosing up to 96 hours post dose

Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)

Time frame: 15 minutes prior to dosing up to 96 hours post dose

Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)

Time frame: 15 minutes prior to dosing up to 96 hours post dose

Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax

Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

Data from ClinicalTrials.gov

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