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

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.

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