A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144

Part of paid clinical trials in Mesa, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07783308
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • AZD4144 — DRUG
    Single oral dose of AZD4144 in participants from all groups

Study Details

This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched controls with normal hepatic function.

Key Dates

First listed
Aug 24, 2026
Start date
Aug 24, 2026
Status verified
Jul 2026
Primary completion
May 28, 2027
Completion
May 28, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Participants with mild hepatic impairment (CP Class A, score of 5 or 6)
  • Experimental: Group 2
    Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
  • Experimental: Group 3
    Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
  • Experimental: Group 4
    Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the impaired groups

Primary Outcome Measure

PK parameters AUCinf [ Time Frame: Day 0 through Day 7 or 9 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Research SiteMesaArizona85210-
Research SiteMiami LakesFlorida33014-
Research SiteOrlandoFlorida32809-
Research SiteAustinTexas78757-

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