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A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment
CompletedPhase 1
Sponsor: AstraZeneca
Conditions: Renal Impairment
Interventions: AZD5462
Countries: Bulgaria
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AZD5462 in participants with impaired renal function.
Eligibility overview
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility criteria
Main Inclusion Criteria: Healthy matched participants (cohort2): * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Stable renal function (eg, no clinically significant change in an eGFR within 3 months or longer prior to study screening), as determined by the investigator. * An eGFR of ≥ 90 mL/min/1.73 m2, as determined at Screening Visit using the CKD-EPI 2021 creatinine only equation. Participants With Renal Impairment: * Participants with severe renal impairment (Cohort 1) must have an eGFR ≥ 15 to \< 30 mL/min/1.73 m2, as determined at Screening Visit using the CKD-EPI 2021 creatinine only equation and not on dialysis. * Participants with moderate renal impairment (Cohort 3) must have an eGFR of ≥ 30 to \< 60 mL/min/1.73 m2, as determined at Screening Visit using the CKD-EPI 2021 creatinine only equation and not on dialysis. * Stable renal impairment (eg, no clinically significant change in eGFR within 3 months or longer prior to study screening), for both Cohorts 1 and 3, as determined by the investigator. * BMI within the range ≥ 18 to \< 35 kg/m2, inclusive. * Females of non-childbearing potential and males. Main Exclusion Criteria: * As judged by the investigator, any evidence of clinically significant disease or abnormal findings in screening assessments which in the investigator's opinion makes it undesirable for the participant to participate in the study. * Positive HCV Ab, HBsAg, or HBcAb, HIV at screening. Healthy Matched Participants (Cohort 2): • Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment, or coagulation disorders) which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the result of the study, or the participant's ability to participate in the study. Participants With Renal Impairment: * Presence of unstable medical (eg, diabetes) or psychological conditions which, in the opinion of the investigator, would compromise the participant's safety or successful participation in this study. * Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury. Use of concurrent medication, which affects creatinine clearance such as cephalosporin antibiotics, ascorbic acid, trimethoprim, cimetidine, quinine within 7 days of Day -1.
Locations (1)
- Sofia, Bulgaria