COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-02-04
Study Completion:2025-09-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06812780

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant with a diagnosis of stable hepatic impairment
  2. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
  1. * Participant has eGFR \< 60 mL/minute/1.73 m2
  2. * Positive test for HIV at screening
  3. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
  4. * History of severe dermatological disorders

Contacts and Locations

Study Locations (Sites)

Research Site
Chandler, Arizona, 85225
United States
Research Site
Rialto, California, 92377
United States
Research Site
Miami Lakes, Florida, 33014
United States
Research Site
Orlando, Florida, 32809
United States
Research Site
San Antonio, Texas, 78215
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-04
Study Completion Date2025-09-04

Study Record Updates

Study Start Date2025-02-04
Study Completion Date2025-09-04

Terms related to this study

Keywords Provided by Researchers

  • Mild
  • Moderate
  • Severe
  • Matched Healthy Controls
  • Liver Fibrosis
  • Liver Cirrhosis

Additional Relevant MeSH Terms

  • Hepatic Impairment