NCT02831517

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

A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy
• Trigeminal Neuralgia

Interventions

Type	Name	Description
DRUG	BIIB074	Administered as specified in the treatment arm
DRUG	Placebo	Matched Placebo

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-07-13
• Last updated: 2017-03-09

Locations

1 site across 1 country: United Kingdom