Key result
XV459 concentrations of 10 to 20 ng/ml yielded 40% to 80% inhibition of platelet aggregation in healthy male volunteers.
Why the study?
What are the pharmacokinetic and pharmacodynamic properties of roxifiban (XV459) in healthy male volunteers?
Population
41 healthy male volunteers
Design
RCT, randomized, sequential, rising multiple-dose
Follow-up
7 to 10 days
Authors
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Informs initial dosing targets for platelet inhibition; extends PK/PD characterization of roxifiban in healthy volunteers.
RCT (n=41)
Sequential
What are the pharmacokinetic and pharmacodynamic properties of roxifiban (XV459) in healthy male volunteers?
A PK/PD model of roxifiban (XV459) demonstrates that plasma concentrations of 10-20 ng/ml achieve 40-80% platelet inhibition, though platelet binding limits the utility of plasma concentration monitoring.
Fossler et al. (2002) conducted an RCT in Healthy (n=41). XV459 was evaluated on Pharmacokinetic/pharmacodynamic (PK/PD) model parameters and percent inhibition of platelet aggregation (%IPA). XV459 concentrations of 10 to 20 ng/ml yielded 40% to 80% inhibition of platelet aggregation in healthy male volunteers.
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