Clinical Trial: A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Cyclosporin

Brief 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 Summary:

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.


Sponsor: BioCryst Pharmaceuticals

Current Primary Outcome:

  • Cmax of probe substrate [ Time Frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period ]
  • AUClast of probe substrate [ Time Frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period ]
  • AUCinf of probe substrate [ Time Frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • adverse events [ Time Frame: absolute and change from baseline through end of study, approximately 30 days ]
  • laboratory analyses [ Time Frame: absolute and change from baseline through end of study, approximately 30 days ]
  • vital signs [ Time Frame: absolute and change from baseline through end of study, approximately 30 days ]
  • physical examination findings [ Time Frame: absolute and change from baseline through end of study, approximately 30 days ]
  • electrocardiograms [ Time Frame: absolute and change from baseline throughend of study, approximately 30 days ]


Original Secondary Outcome: Same as current

Information By: BioCryst Pharmaceuticals

Dates:
Date Received: April 24, 2017
Date Started: February 17, 2017
Date Completion: August 15, 2017
Last Updated: May 1, 2017
Last Verified: April 2017