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NCT06812780CompletedPhase 1

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

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)

Source: ClinicalTrials.gov · Last updated 24 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
35 (actual)
First submitted
3 Feb 2025
Start date
4 Feb 2025
Primary completion date
4 Sept 2025
Lead sponsor
AstraZeneca
NCT number
NCT06812780

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 35
  • From 4 Feb 2025 to the primary completion date, 4 Sept 2025
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Positive test for HIV at screening
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
  • History of severe dermatological disorders

Lab values

  • Participant has eGFR \< 60 mL/minute/1.73 m2

Who the study is looking for

  • For Hepatic:
  • Participant with a diagnosis of stable hepatic impairment
    • For Healthy:
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
    • All participants:
    • \- Body weight ≥ 50 kg; BMI within the range of 18.0 to 42.0 kg/m2 (inclusive).

Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
ChandlerUnited StatesUnknown status
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Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
RialtoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.