Clinical Trial: A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Ef
Brief 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.
Detailed Summary:
Sponsor: BioCryst Pharmaceuticals
Current Primary Outcome: Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules [ Time Frame: Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations [ Time Frame: Screening through study completion (approximately 61 days) ]
- Plasma pharmacokinetics to assess the effect of food on BCX4161 [ Time Frame: Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling ]
Original Secondary Outcome: Same as current
Information By: BioCryst Pharmaceuticals
Dates:
Date Received: April 24, 2014
Date Started: April 2014
Date Completion:
Last Updated: August 14, 2014
Last Verified: August 2014
