A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions

• Status: Completed
• Trial end date: 2017-08-15
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, three part study to evaluate the effect of BCX7353 on drug transporters as well as the effect of an inhibitor of drug transport on BCX7353.

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

Details

• Lead Sponsor: BioCryst Pharmaceuticals
• Treatments: Berotralstat; Cyclosporine; Cyclosporins; Digoxin; Rosuvastatin Calcium

Criteria

Key Inclusion Criteria:

• written informed consent

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

• creatinine clearance of at least 80 mL/min by Cockcroft-Gault equation

• complies with all required study procedures and restrictions

Key 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

• use of medication that is known to inhibit or induce metabolic enzymes or transporters within 30 days of dosing

• 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

• history of severe hypersensitivity to any medicinal product

• for subjects enrolled in cohort 1, current use of antibiotics or probiotics, or use within 6 months prior to Day 1