Population Pk Analysis Of Dx-9065a In Patients With Acute Coronary Syndrome

Background/Aim To evaluate the population Pharmacokinetics(PK) of DX-9065a(DX). Methods Plasma concentration data from Phase I and patients with Acute Coronary Syndrome (ACS) were modeled using population PK approach (NONMEM®). Design Data from 7 studies were analyzed retrospectively. Settings Subjects were both hospitalized or out-patient. Participants 271 Intervention Dosing schemes varied from single injection to bolus following continuous infusion. Results A four-compartment mamillary PK model with first-order elimination described the data. Low interindividual variability in clearance (CL) allows confidence in dose selection. DX CL was found to be correlated with creatinine CL and body weight. CL was also found to be gender-dependent, 14.1 % less in females compared to males, however this effect is unlikely to be of clinical significance. Conclusions DX require dose adjustment in subject with moderate to severe impairment and in obese subjects. Gender had a minor impact on PK. Race did not influence the PK of DX in this analysis. Clinical Pharmacology & Therapeutics (2005) 77, P89–P89; doi: 10.1016/j.clpt.2004.12.232