NCT03136237

A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions

A Phase 1 Study to Evaluate the Effect of BCX7353 on the Single Dose Pharmacokinetics of the P-gp Substrate Digoxin and the BCRP Substrate Rosuvastatin and the Effect of the P-gp Inhibitor Cyclosporine on the Single Dose Pharmacokinetics of BCX7353

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: BioCryst Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single center, open-label, fixed-sequence, drug interaction study to evaluate the effect of BCX7353 on the pharmacokinetics of the P-gp substrate digoxin and the BCRP substrate rosuvastatin, as well as the effect of the P-gp inhibitor cyclosporine on the pharmacokinetics of BCX7353. It is planned that 54 subjects will be enrolled into 3 cohorts of 18 subjects each. Cohort 1 will evaluate the effects of multiple doses of BCX7353 on single-dose pharmacokinetics of digoxin. Cohort 2 will evaluate the effect of multiple doses of BCX7353 on the pharmacokinetics of rosuvastatin. Cohort 3 will evaluate the effect of a single dose of cyclosporine on the pharmacokinetics of BCX7353. Cohorts may be dosed in parallel or in any order.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	BCX7353	Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3
DRUG	Digoxin	Day 1 of Cohort 1
DRUG	BCX7353 + digoxin	Day 19 of Cohort 1
DRUG	Rosuvastatin	Day 1 of Cohort 2
DRUG	rosuvastatin + BCX7353	Day 15 of Cohort 1
DRUG	Cyclosporine + BCX7353	Day 14 of Cohort 3

Timeline

• Start date: 2017-02-17
• Primary completion: 2017-08-15
• Completion: 2017-08-15
• First posted: 2017-05-02
• Last updated: 2017-10-26

Locations

1 site across 1 country: United Kingdom