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A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693

NCT05919069

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Hepatic Impairment

Interventions: AZD2693

Countries: United States

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (3)

Rialto, California, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States