A Relative Bioavailability Study of Two Formulations of BCX7353

• Status: Completed
• Trial end date: 2017-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect

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

Details

• Lead Sponsor: BioCryst Pharmaceuticals
• Treatments: Berotralstat

Criteria

Inclusion Criteria:

• written informed consent

• acceptable birth control measures for male subjects and women of childbearing potential

• complies with all required study procedures and restrictions

Exclusion Criteria:

• clinically significant medical history, current medical or psychiatric condition

• clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline

• current use, or use of any prescribed or over the counter medication, vitamins or herbal products within 14 days of Day 1

• participation in any other investigational drug study within 90 days of screening

• recent or current history of alcohol or drug abuse

• regular recent use of tobacco or nicotine products

• positive serology for HBV, HCV, or HIV

• pregnant or nursing

• donation or loss of greater than 400 mL of blood within the previous 3 months