NCT05112419

A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate Renal Impairment

A Single Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Zibotentan in Healthy Participants Compared to Participants With Moderate Hepatic and Moderate Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hepatic Impairment
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Zibotentan	All participants will receive a single oral dose of zibotentan capsule under fasted conditions.

Timeline

• Start date: 2021-11-10
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2021-11-08
• Last updated: 2022-01-27

Locations

1 site across 1 country: Bulgaria

Regulatory

• FDA-regulated drug study