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Clinical Trial Details

Trial ID: L1405
Source ID: NCT06693765
Associated Drug: Azd4144
Title: 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
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Renal Impairment|End-stage Kidney Disease|Healthy Participants
Interventions: DRUG: AZD4144
Outcome Measures: Primary: Observed maximum plasma concentration (Cmax), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 14|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 14|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 14|Apparent total body clearance (CL/F), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 14|Non-renal clearance of drug from plasma (CLNR/F), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 14|Apparent volume of distribution based on the terminal phase (Vz/F), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 14|Terminal elimination half-life (t½λz), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 14|Renal clearance of drug from plasma (CLR), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 4|Amount excreted (Ae), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 4|Percentage of dose excreted unchanged in urine (fe), To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants., From Day 1 to Day 4 | Secondary: Number of Treatment Emergent Adverse Events (TEAEs), To evaluate the safety and tolerability of AZD4144 single dose in participants with severe renal impairment, ESKD, and their healthy controls., From Day 1 to Follow-up (Day 14/28)
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Parexel
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-18
Completion Date: 2025-06-02
Results First Posted:
Last Update Posted: 2025-04-03
Locations: Research Site, Sofia, 1612, Bulgaria|Research Site, Bucuresti, 010731, Romania
URL: https://clinicaltrials.gov/show/NCT06693765