NCT02125162

A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161

A Single-dose, Randomized, 3-period, Crossover Study to Evaluate the Relative Bioavailability of BCX4161 Formulated as a Soft Gelatin Capsule to BCX4161 Formulated as a Hard Gelatin Capsule and the Effect of Food on BCX4161 Pharmacokinetics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: BioCryst Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare how the body takes up and then eliminates the study drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule. This study will also evaluate whether food has any effect on how the body takes up BCX4161.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	BCX4161	Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-04-29
• Last updated: 2014-08-15

Locations

1 site across 1 country: United Kingdom