A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389

Description

The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.

Conditions

Hepatic Impairment

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Study Overview

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Study Details

Study overview

The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.

A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (CAMPOLINA)

A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389

Condition
Hepatic Impairment
Intervention / Treatment

-

Contacts and Locations

Rialto

Research Site, Rialto, California, United States, 92377

Miami Lakes

Research Site, Miami Lakes, Florida, United States, 33014

Orlando

Research Site, Orlando, Florida, United States, 32809

San Antonio

Research Site, San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant with a diagnosis of stable hepatic impairment
  • * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
  • * Participant has eGFR \< 60 mL/minute/1.73 m2
  • * Positive test for HIV at screening
  • * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
  • * History of severe dermatological disorders

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2025-12-16