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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
CompletedPhase 1
Sponsor: AstraZeneca
Conditions: Renal Impairment, End-stage Kidney Disease, Healthy Participants
Interventions: AZD4144
Countries: Bulgaria, Romania
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 overview
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility 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 (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.
Locations (2)
- Sofia, Bulgaria
- Bucharest, Romania