A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780

Part of paid clinical trials in Lake Forest, California.

Sponsor
AstraZeneca
Study ID
NCT06592482
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • AZD0780 — DRUG
    A single "A" dose of AZD0780 will be administered in the morning on Day 1 under fasted condition. Study intervention will be administered orally with approximately 240 mL of water.

Study Details

This is a Phase I, multi-centre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 in male and female participants (females of non-childbearing potential) with severe renal impairment not on dialysis, end-stage renal disease (ESRD) on intermittent haemodialysis (HD), or moderate renal impairment (optional) compared with male and female participants (females of non-childbearing potential) with normal renal function. Potential participants will be screened to assess their eligibility to enter the study up to 4 weeks prior to administration of study intervention. Eligible participants will be admitted to the study site on Day -1. On Day 1, an "A" single oral dose of AZD0780 will be administered, and participants will be confined to the study site until after assessments are completed on Day 11.

Key Dates

Start date
Aug 2, 2024
Status verified
Feb 2025
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024

Study Design

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

Arms

  • Experimental: Group 1: AZD0780
    Participants with severe renal impairment (eGFR \< 30 mL/min), not on dialysis.
  • Experimental: Group 2: AZD0780
    Participants with ESRD (eGFR \< 15 mL/min) on a stable intermittent HD schedule for at least 3 months prior to planned dosing.
  • Experimental: Group 3: AZD0780
    Participants with normal renal function demographically matched by sex, age, and body mass index (BMI) to the impaired participants (eGFR of ≥ 90 mL/min)
  • Experimental: Group 4 (optional): AZD0780
    Participants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min).

Primary Outcome Measure

AUClast [ Time Frame: From Day 1 to Day 11 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteLake ForestCalifornia92630-
Research SiteHialeahFlorida33014-
Research SiteOrlandoFlorida32808-
Research SiteOrlandoFlorida32809-
Research SiteSaint PaulMinnesota55114-

Find similar trials in Lake Forest, CA

By research site
Research Site· Lake Forest, CAResearch Site· Hialeah, FLResearch Site· Orlando, FLResearch Site· Saint Paul, MN

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