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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: BioCryst Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Written informed consent

• Body mass index 19 to 32 kg/m2 and a weight of at least 50 kg

• Abide by study restrictions

• Attend all study visits

• Acceptable birth control measures

Key Exclusion Criteria:

• Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality

• Activated partial thromboplastin time or prothrombin time outside of normal laboratory limits

• Pregnant or nursing

• Recent history of alcohol abuse or positive drugs of abuse screen

• Current smokers

• Donation or loss of greater than 400 mL of blood within 3 months