Status:
COMPLETED
A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
Lead Sponsor:
AstraZeneca
Conditions:
Renal Impairment
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
This is a Phase I, multi-centre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 in male and female participants (females of non-ch...
Detailed Description
This is a Phase I, multi-centre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 in male and female participants (females of non-ch...
Eligibility Criteria
Inclusion
- \- Participant must be 18 to 85 years of age, inclusive at the time of signing ICF
- For Participants with normal renal function:
- \- Participant must be medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1
- For Participants with renal impairment:
- Diagnosis of chronic kidney disease, stable renal function in the 6 months prior to dosing
- Received HD for chronic renal failure for at least 3 months prior to dosing (Group 2)
- Participants with renal impairment, as follows, based on CKD-EPI equation (BSA-adjusted eGFR) at screening: Group1 eGFR \< 30 mL/min), not requiring dialysis, Group 2 ESRD (eGFR \< 15 mL/min) on a stable intermittent HD schedule for at least 3 months prior to planned dosing and Group 4 (optional) moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min)
- Male participants:
- Males must be surgically sterile or using, in conjunction with their female partner, a highly effective method of contraception for the duration of the study (from the time of study intervention administration) until 3 months after discharge to prevent pregnancy in a partner.
- Female participants of non-childbearing potential:
- Female participants must not be pregnant and must have a negative pregnancy test at screening and check-in, must not be lactating, and must not be of childbearing potential.
Exclusion
- For Participants with normal renal function:
- 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).
- Use of any prescription or non-prescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before study intervention, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- History of any major surgical procedure within 30 days prior to study intervention.
- For Participants with renal impairment:
- Presence of unstable medical or psychological conditions which, in the opinion of the investigator, would compromise the participant's safety or successful participation in this study.
- Renal transplant patients (participants on HD with non-functioning renal transplants are not excluded), participants waiting for organ transplant scheduled to occur during the study, and those with a history of acute kidney injury occurring within 3 months prior to screening.
- History of any major surgical procedure within 30 days prior to study intervention.
- Current or previous treatment with drugs for reduction or inhibition of PCSK9 (eg, evolocumab, alirocumab, or inclisiran).
- Use of moderate/strong inhibitors or inducers of CYP3A4/5.
- Unable to refrain from potassium binders, phosphate binders (eg, aluminium hydroxide and calcium carbonate), cholestyramine/colestipol, and ranitidine/nizatidine within 10 hours before and 10 hours after study intervention.
- Receiving or has received within 14 days of screening, medication that contains a black box warning for significant QT prolongation. A list of prohibited medications can be found in protocol.
- Use of concurrent medication which affects calculation of eGFR by affecting serum creatinine (eg, cephalosporin antibiotics, ascorbic acid, trimethoprim, cimetidine, or quinine) within 7 days of Day -1.
Key Trial Info
Start Date :
August 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06592482
Start Date
August 2 2024
End Date
December 1 2024
Last Update
February 20 2025
Active Locations (5)
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1
Research Site
Lake Forest, California, United States, 92630
2
Research Site
Hialeah, Florida, United States, 33014
3
Research Site
Orlando, Florida, United States, 32808
4
Research Site
Orlando, Florida, United States, 32809