Investigating the effects of liver impairment on the drug 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)

This study is testing how safe and well-tolerated the drug AZD2389 is for people with liver problems compared to those with healthy livers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 4 sites (Rialto, California and 3 other locations)
• Trial ID: NCT06812780 on ClinicalTrials.gov

What this trial studies

This study examines the safety and tolerability of AZD2389 in individuals with varying degrees of hepatic impairment compared to those with normal liver function. It is a single-dose, non-randomized, open-label, parallel-group study that includes participants with mild, moderate, and severe hepatic impairment, as well as matched healthy controls. The study aims to gather pharmacokinetic data and assess fibroblast activation protein activity, safety, and tolerability of the drug over a 48-hour period post-dose.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with stable hepatic impairment or healthy participants with normal liver function.

Not a fit: Patients with severe renal impairment, significant allergies, or severe dermatological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the safe use of AZD2389 in patients with liver impairment, potentially leading to better treatment options.

How similar studies have performed: Other studies have explored drug safety in hepatic impairment, but the specific evaluation of AZD2389 in this context is novel.

Eligibility criteria

Inclusion Criteria:

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).

Exclusion Criteria:

* 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

Where this trial is running

Rialto, California and 3 other locations

• Research Site — Rialto, California, United States (Not_yet_recruiting)
• Research Site — Miami Lakes, Florida, United States (Recruiting)
• Research Site — Orlando, Florida, United States (Recruiting)
• Research Site — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Hepatic Impairment; Mild; Moderate; Severe; Matched Healthy Controls; Liver Fibrosis; Liver Cirrhosis