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New Formulation and Food Effect Study of BIIB074

NCT02951221 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-02-27

No results posted yet for this study

Summary

The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.

Conditions

  • Trigeminal Neuralgia (TN)
  • Other Neuropathic Pain

Interventions

DRUG

BIIB074 Treatment A

Lower dose RCF fasted

DRUG

BIIB074 Treatment B

Lower dose DCF fasted

DRUG

BIIB074 Treatment C

Higher dose DCF fasted

DRUG

BIIB074 Treatment D

Higher dose DCF fed

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

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Entities

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 NCT02951221 on ClinicalTrials.gov