A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate … (NCT05112419) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate Renal Impairment
Bulgaria12 participantsStarted 2021-11-10
Plain-language summary
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of zibotentan in patients with moderate hepatic and moderate renal impairment in comparison to a matched healthy control group.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Body weight of at least 50 kg and body mass index within the range of 18 and 35 kg/m\^2 (inclusive).
* Female of non-childbearing potential or male
Participants with Moderate Hepatic Impairment and Moderate Renal Impairment only (Cohort 1)
* An estimated glomerular filtration rate (eGFR) in the range of 30 to 45 mL/min/1.73m\^2 (inclusive) as determined using the Chronic Kidney Disease Epidemiology Collaboration formula, at Screening. Retesting for eGFR may be repeated twice during Screening Period.
* Confirmed clinical diagnosis of cirrhosis with either ascites or moderate hepatic impairment (Childs-Pugh B). Supporting documents confirming the participant's hepatic impairment must be available. The participant must be classified by the Investigator or usual practitioner as Child-Pugh Class B or having radiographic or clinical evidence of ascites of any grade.
* Stable hepatic impairment (eg, no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 28 days prior to Screening, as determined by the Investigator or usual practitioner).
Healthy Participants only (Cohort 2)
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and clinical laboratory tests.
* An eGFR of ≥ 90 mL/min/1.73m\^2 as determined using the CKD-EPI formula at Screening.
* No clinically significant liver or kidney disease as judged by the Investigator.
Exclus…
What they're measuring
1
Area under plasma concentration-time curve from time zero to infinity (AUCinf)
Timeframe: Day 1 to Day 6
2
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)