A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07546760
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • AZD6234 — DRUG
    Single subcutaneous dose of AZD6234 in participants from all groups
  • AZD9550 — DRUG
    Single subcutaneous dose of AZD9550 in participants from all groups

Study Details

The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function.

Key Dates

Start date
Mar 20, 2026
Status verified
Jun 2026
Primary completion
Feb 4, 2027
Completion
Feb 4, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Group 1
    Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
  • Experimental: Group 2
    Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
  • Experimental: Group 3
    Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment.

Primary Outcome Measure

PK parameters AUCinf [ Time Frame: Day 0 through Day 56 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Research SiteChandlerArizona85225-
Research SiteRialtoCalifornia92377-
Research SiteMiami LakesFlorida33014-
Research SiteSan AntonioTexas78215-

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Research Site· Chandler, AZResearch Site· Rialto, CAResearch Site· Miami Lakes, FLResearch Site· San Antonio, TX

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