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

Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
Bulgaria
Research Site
Sofia
Romania
Research Site
Bucharest
Time Frame
Start Date: 2024-11-18
Completion Date: 2025-04-23
Participants
Target number of participants: 41
Treatments
Experimental: Cohort 1: AZD4144
Participants with severe renal impairment will receive a single oral dose of AZD4144 on Day 1.
Experimental: Cohort 2: AZD4144
Healthy participants with normal renal function will receive a single oral dose of AZD4144 on Day 1.
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.
Experimental: Cohort 4: AZD4144
Participants with moderate renal impairment will receive a single oral dose of AZD4144 on Day 1.
Experimental: Cohort 5: AZD4144
Participants with mild renal impairment will receive a single oral dose of AZD4144 on Day 1.
Sponsors
Leads: AstraZeneca
Collaborators: Parexel

This content was sourced from clinicaltrials.gov

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