Absolute BA and OZ439 PK Effect of Different OZ439 Dose Volumes and Cobicistat Co-administration Study

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2017
Primary objectives of this study are: ‐ to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439 dispersion and a simultaneous single intravenous (iv) microdose (100 μg) infusion of [14C]‐OZ439 under fasted conditions (Part 1) ‐ To evaluate the effects of a single oral dose of cobicistat, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetic (PK) profile of a single oral dose of a dispersion of OZ439 simple granules under fasted conditions (Part 2) ‐ To evaluate the PK of single doses of OZ439 granules when restricting the target dosing volumes to 64.5 or 100 mL (Parts 1 and 2) Secondary objectives are: ‐ To assess the safety and tolerability of OZ439 when administered alone, and to assess the safety and tolerability of OZ439 and cobicistat when co���administered as single doses to healthy subjects (Parts 1 and 2) ‐ To determine the PK parameters of OZ439 single iv microdose (100 μg) infusion of [14C]‐OZ439 (Part 1) ‐ To assess the effects of the total dosing volume and of dose to volume ratio on OZ439 PK under fasted conditions (Parts 1 and 2) ‐ To determine the PK parameters and exposures of cobicistat (Part 2)
Epistemonikos ID: e6c70fc75d09059d8a048f24c5b6360891bc974f
First added on: May 22, 2024