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A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AZD5462 in participants with impaired renal function.
This is a Phase I, single dose, non-randomised, open-label, parallel group study to assess the PK, safety, and tolerability of AZD5462 in male and female participants (females of non-childbearing potential) with renal impairment. This study consists of 3 cohorts: 1. Cohort 1: Participants with severe renal impairment (eGFR ≥ 15 to \< 30mL/min/1.73 m2, not requiring dialysis). 2. Cohort 2: Participants who are healthy control (eGFR ≥ 90 mL/min/1.73 m2) matched at a group level to Cohort 1. 3. Cohort 3 (conditional): Participants with moderate renal impairment (eGFR ≥ 30 to \< 60mL/min/1.73 m2). This study comprises of three periods: * Screening period: 21 days * In-patient (Treatment) period: 4 days * Out-patient visit: On Day 4, participants will return to the study site to undergo safety assessments and provide blood samples 72 hours post-dose. Participants may stay at the study site for this visit if preferred. * Follow-up visit: On Day 7 (± 2), participants will return to the study site for safety assessments. The duration of the study for an individual participant from the Screening Visit to the Follow-up Visit will be approximately 4 weeks.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Research Site
Sofia, Bulgaria
Start Date
November 18, 2024
Primary Completion Date
December 23, 2024
Completion Date
December 23, 2024
Last Updated
December 3, 2025
16
ACTUAL participants
AZD5462
DRUG
Lead Sponsor
AstraZeneca
NCT07154901
NCT07165015
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06352411