Study identifier:D9440C00003
ClinicalTrials.gov identifier:NCT06693765
EudraCT identifier:N/A
CTIS identifier:2024-513848-28-00
A Single Dose, Non-randomised, Open-label, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants with Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants
Renal Impairment, Healthy Participants
Phase 1
Yes
AZD4144
All
24
Interventional
18 Years - 80 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
PAREXEL
A study to investigate the pharmacokinetics, safety, and tolerability of AZD4144 in participants with severe renal impairment, end-stage kidney disease, and in healthy participants
This is an open-label, single dose, non-randomised, parallel group, Phase I study to assess the pharmacokinetics, safety, and tolerability of AZD4144 in male and female participants with severe renal impairment and end-stage kidney disease (ESKD) compared with healthy control participants. The study will comprise of: - A Screening Period of 21 days. - Cohort 1 and 2: a single Treatment Period with an in-clinic period of 7 days. - Cohort 3: two Treatment Periods each with an in-clinic period of 7 days, and a washout period of 6 days after the in-clinic treatment period. - A Follow-up visit 7 days following discharge.
Location
Status
Location
Bucuresti, Romania, 010731
Status
Recruiting
Location
Sofia, Bulgaria, 1612
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1: AZD4144 Participants with severe renal impairment will receive a single oral dose of AZD4144 on Day 1. | Drug: AZD4144 AZD4144 will be administered orally. |
Experimental: Cohort 2: AZD4144 Healthy participants with normal renal function will receive a single oral dose of AZD4144 on Day 1. | Drug: AZD4144 AZD4144 will be administered orally. |
Experimental: Cohort 3: AZD4144 Participants with ESKD on intermittent haemodialysis will receive a single oral dose of AZD4144 on the first day of Treatment Period 1 and Treatment Period 2. | Drug: AZD4144 AZD4144 will be administered orally. |
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