XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce that dosing of human subjects has been initiated in the XRX-OXY-101 bridging pharmacokinetics study (“PK Study”).
Successful recruitment for part 1 of this 3-part clinical trial has been completed with 32 subjects receiving study drug. Following administration of the first dose of drug, blood sampling and bioanalytical evaluation will be conducted to characterize the pharmacokinetics and bioavailability of the XRx-008 program’s novel proprietary formulations of oxypurinol for future clinical trials development. Additionally, this PK Study will provide fundamental information for the 505(b)2 filing of the XRx-008 program.
XORTX’s current conducting our clinical trial - XRX-OXY-101 - a “bridging pharmacokinetics” study. Part 1 of the study involves dosing under fasted conditions. Part 2 measures the effect of food on pharmacokinetics (PK) and Part 3 is a multiple dose PK evaluation. Safety evaluation is also an important aspect of the XRX-OXY-101 clinical trial. The study is designed to permit XORTX to characterize the safety and relative bioavailability of the XRx-008 program formulations. Knowledge gained during the conduct of this trial will provide critical guidance regarding the oral dose for our planned registration trial in autosomal dominant polycystic kidney disease (ADPKD).
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