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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Covance CRU
Leeds, United Kingdom
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
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
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Day 1 of Cohort 2
Day 15 of Cohort 1
Day 14 of Cohort 3