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

NCT02831517 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-03-09

No results posted yet for this study

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

DRUG

BIIB074

Administered as specified in the treatment arm

DRUG

Placebo

Matched Placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02831517 on ClinicalTrials.gov