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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca

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