A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
Key facts
- Study ID
- NCT05919069
- Run by
- AstraZeneca
- People needed
- 35
- Starts
- 2023-06-16
- Expected to finish
- 2024-09-16
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- For Hepatic:
- Participant with a diagnosis of chronic and stable hepatic impairment
- For Healthy:
- Participant with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or 12-lead ECGs,
- All participants:
- Body weight ≥ 50 kg; BMI within the range of 18.0 to 40.0 kg/m2 (inclusive) as measured at screening
You may not qualify if…
- Participant with impaired hepatic function has eGFR < 60 mL/minute/1.73 m2 and participant with normal hepatic function has eGFR < 90 mL/minute/1.73 m2
- Positive test for HIV at screening
- History or presence of clinically significant thyroid disease
- History or presence of clinically significant or unstable medical or psychiatric condition
- History of any major surgical procedure within 30 days prior to study intervention
Where it is running
- Research Site — Rialto, California, United States
- Research Site — Miami Lakes, Florida, United States
- Research Site — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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