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Completed

NCT Number: NCT06693765

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

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.

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Key information

Conditions

Renal Impairment Chronic Disease Disease Attributes End-stage Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Participants Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Sofia, Bulgaria

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About this study

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, 2, 4, and 5: 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 (Cohorts 1, 4 and 5)

  • Participants who have renal impairments.
  • Cohort 1 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 4 participants with moderate renal impairment must have an eGFR of ≥ 30 to < 60 mL/min/1.73m2.
  • Cohort 5 participants with mild renal impairment must have an eGFR of ≥ 60 to < 90 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 (Cohorts 1, 4, 5).
  • Use of any of the prohibited medications in the 4 weeks prior to Visit 1 (Cohorts 1, 3, 4, 5).
  • Participants with a known hypersensitivity to AZD4144 or any of the excipients of the product.

Treatment and study plan

AZD4144

Drug

AZD4144 will be administered orally.

Primary outcomes

  1. Observed maximum plasma concentration (Cmax)

    Time frame: From Day 1 to Day 14

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf)

    Time frame: From Day 1 to Day 14

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)

    Time frame: From Day 1 to Day 14

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  4. Apparent total body clearance (CL/F)

    Time frame: From Day 1 to Day 14

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  5. Non-renal clearance of drug from plasma (CLNR/F)

    Time frame: From Day 1 to Day 14

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  6. Apparent volume of distribution based on the terminal phase (Vz/F)

    Time frame: From Day 1 to Day 14

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  7. Terminal elimination half-life (t½λz)

    Time frame: From Day 1 to Day 14

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  8. Renal clearance of drug from plasma (CLR)

    Time frame: From Day 1 to Day 4

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  9. Amount excreted (Ae)

    Time frame: From Day 1 to Day 4

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  10. Percentage of dose excreted unchanged in urine (fe)

    Time frame: From Day 1 to Day 4

    To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

  11. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From Day 1 to Follow-up (Day 14/28)

    To evaluate the safety and tolerability of AZD4144 single dose in participants with severe renal impairment, ESKD, and their healthy controls.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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