NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06812780

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Hepatic Impairment

Interventions: AZD2389

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (5)
  • Chandler, Arizona, United States
  • Rialto, California, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • San Antonio, Texas, United States