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

Study identifier:D9440C00003

ClinicalTrials.gov identifier:NCT06693765

EudraCT identifier:N/A

CTIS identifier:2024-513848-28-00

Recruiting

Official Title

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

Medical condition

Renal Impairment, End-stage kidney disease, Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD4144

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 18 Nov 2024

Estimated Primary Completion Date: 03 Mar 2025

Estimated Study Completion Date: 03 Mar 2025

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2025 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

Healthy Matched Control Participants Only (Cohort 2):
- Stable renal function (for example, no clinically significant change in an estimated glomerular filtration rate (eGFR) within 3 months or longer prior to study the Screening Visit), as determined by the investigator.
- Have an eGFR of ≥ 90 milliliter/minute/1.73m2 (mL/min/1.73m2) as determined via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula without race.
Renally Impaired Participants Only (Cohort 1)
- Participants who have renal impairments.
- Participants with severe renal impairment must have an eGFR ≥ 15 to < 30 mL/min/1.73m2 not on dialysis.
- Cohort 1 should have at least 3 participants with eGFR ≤ 20 mL/min/1.73m2.
Cohort 3
- Participants with ESKD on IHD must have been on stable IHD for at least 3 months prior to Visit 1.
- All renally impaired participants should be on stable standard of care for at least 4 weeks prior to Visit 1.
All cohorts:
- Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range ≥ 18 to ≤ 35 kg/m2, inclusive.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.

Exclusion Criteria

- History of QT prolongation associated with other medications that required discontinuation of that medication.
- Congenital long QT syndrome.
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
- Concomitant immunosuppressive, steroid treatment.
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment) (Cohort 2).
- Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury (Cohort 1).
- Use of any of the prohibited medications in the 4 weeks prior to Visit 1 (Cohorts 1 and 3).
- Participants with a known hypersensitivity to AZD4144 or any of the excipients of the product.

Sort by status

No locations available

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.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]