A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerabili… (NCT05919069) | Clinical Trial Compass
CompletedPhase 1
A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693.
United States35 participantsStarted 2023-06-16
Plain-language summary
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
* 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