Hereditary Angioedema Clinical Trial
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 Cyclosporine on the Single Dose Pharmacokinetics of BCX7353
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.
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.
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