A Phase 1b open label study of the pharmacokinetics and safety of oral OCX063 in adults with chronic kidney disease - Trial ANZCTR12623000732684
Access comprehensive clinical trial information for ANZCTR12623000732684 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by OccuRx Pty Ltd and is currently Not yet recruiting. The study focuses on Chronic kidney disease.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Australian New Zealand Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
OccuRx Pty Ltd
Timeline & Enrollment
Phase 1/2
Sep 30, 2023
N/A
Primary Outcome
Pharmacokinetic (PK) profile of OCX063 including • Peak plasma concentration (Cmax) of OCX063 obtained directly from the plasma concentration data without interpolation. • Time to peak plasma concentration (tmax) of OCX063 obtained directly from the plasma concentration data without interpolation. • Area under the concentration-time curve of OCX063 from time 0 to infinity (extrapolated) (AUC0-inf) • Area Under the Plasma Concentration versus -Time Curve over a dosing interval (tau). Dosing interval is considered as actual time 24 hours (AUCtau) • Accumulation ratio based on Cmax (RCmax) • Accumulation ratio based on AUC (RAUC)
Summary
This is an open label study to measure the PK of oral OCX063, over 28 days of dosing in participants with chronic kidney disease (CKD). The study will be run in sequential cohorts, with the first 6 participants receiving a 50 mg dose of OCX063 per day and the following 6 participants receiving 100 mg OCX063 per day. An additional dose cohort of 25 mg or 75 mg may be added if PK data indicate that a lower dose may provide adequate exposure levels. Safety will also be assessed.
ICD-10 Classifications
Data Source
Australian New Zealand Clinical Trials Registry
ANZCTR12623000732684
Non-Device Trial