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Clinical Trial 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.


Clinical Trial Description

This is a single-dose, non-randomised, open-label, parallel-group study. All participants will receive a single oral dose of 5 mg zibotentan under fasted conditions and will be involved in the study for approximately 5 weeks. Approximately 12 participants will be enrolled into each one of the 2 cohorts and receive the study intervention: - Cohort 1: 12 participants with moderate hepatic impairment and moderate renal impairment as assessed at Screening - Cohort 2: 12 healthy participants matched for age (± 10 years), gender, and BMI (± 20%) on a group level to participants in Cohort 1 The study will comprise of the following study periods: - A Screening Period of maximum 28 days (before dosing): participants will be screened for eligibility. - A Residential Period of 8 days: participants will be admitted to the study centre in the evening on Day - 2, two days before administration of a single oral dose of zibotentan (Day 1). Participants will have final study assessments on Day 6 (120 hours post-dose) and will be discharged that day. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05112419
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date November 8, 2021
Completion date January 24, 2022

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