NCT02951221

New Formulation and Food Effect Study of BIIB074

A Phase 1, Open-label Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB074 and to Assess the Effect of Food on BIIB074 Pharmacokinetics in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-11-01
• Last updated: 2017-02-27

Locations

1 site across 1 country: United States