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

Launched by ASTRAZENECA · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called AZD2389 to see how it affects people with liver problems (hepatic impairment) compared to those who have healthy liver function. The goal is to understand how safe the medication is and how well the body tolerates it in both groups. The trial is currently looking for participants aged 65 to 74 years, as well as younger adults up to 45 years old, and it welcomes individuals of all genders.

To be eligible for the study, participants with liver issues must have a stable diagnosis of hepatic impairment. Healthy participants should be in good overall health, confirmed by medical tests and evaluations. All participants need to weigh at least 50 kg and fall within a specific range for body mass index (BMI). Those with certain health conditions, like serious kidney problems or significant allergies, will not be able to participate. Participants can expect to be closely monitored during the trial to ensure their safety and well-being.

Gender

ALL

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