New drug AZD5462 tested in kidney patients for safety
NCT ID NCT06661733
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 study looked at how the drug AZD5462 behaves in people with reduced kidney function compared to healthy volunteers. Sixteen participants received a single oral dose, and researchers measured drug levels in the blood and monitored for side effects. The goal was to understand if kidney impairment changes how the drug is processed, which helps guide future dosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD5462
- What this could lead to
- If successful, this study could help determine the right dose of AZD5462 for people with kidney problems in future trials.
- What could go wrong
- This is a very early, small study (16 people) focused on drug levels and safety, not on treating any disease. Results may not apply to larger populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
16 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Dec 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Sofia, 1612, Bulgaria
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Other studies related to the condition(s) this trial covers.
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