Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780

Part of paid clinical trials in Hialeah, Florida.

Sponsor
AstraZeneca
Study ID
NCT06576765
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of AZD0780 with moderate and possibly mild hepatic impairment in comparison to a matched healthy control group.

Key Dates

Start date
Aug 8, 2024
Status verified
Feb 2025
Primary completion
Nov 8, 2024
Completion
Nov 8, 2024

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Subjects with Moderate Impairment will receive a single oral dose of AZD0780 under fasted conditions.
  • Experimental: Group 2
    Healthy participants will receive a single oral dose of AZD0780 under fasted conditions.
  • Experimental: Group 3 (optional)
    Subjects with Mild Impairment will receive a single oral dose of AZD0780 under fasted conditions.

Primary Outcome Measure

AUClast [ Time Frame: Day 1 to Day 11 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteHialeahFlorida33014-
Research SiteOrlandoFlorida32809-
Research SiteSan AntonioTexas78215-

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