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

Sponsor
AstraZeneca
Study ID
NCT05112419
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment
  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Zibotentan — DRUG
    All participants will receive a single oral dose of zibotentan capsule under fasted conditions.

Study Details

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.

Key Dates

Start date
Nov 10, 2021
Status verified
Jan 2022
Primary completion
Dec 15, 2021
Completion
Dec 15, 2021

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Participants with moderate hepatic impairment and moderate renal impairment
    Participants will receive a single oral dose of zibotentan under fasted conditions.
  • Experimental: Cohort 2: Healthy participants
    Participants will receive a single oral dose of zibotentan under fasted conditions.

Primary Outcome Measure

Area under plasma concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: Day 1 to Day 6 ]

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