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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
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