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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514359-14-00 | Registry Identifier | EU CT number |
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The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AZD5462 in participants with impaired renal function.
This is a Phase I, single dose, non-randomised, open-label, parallel group study to assess the PK, safety, and tolerability of AZD5462 in male and female participants (females of non-childbearing potential) with renal impairment.
This study consists of 3 cohorts:
This study comprises of three periods:
The duration of the study for an individual participant from the Screening Visit to the Follow-up Visit will be approximately 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants with severe renal impairment (eGFR ≥ 15 to < 30 mL/min/1.73 m2, not requiring dialysis). |
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| Cohort 2 | Experimental | Participants who are healthy control (eGFR ≥ 90 mL/min/1.73 m2) matched at a group level to Cohort 1. |
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| Cohort 3 (conditional) | Experimental | Participants with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min/1.73 m2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5462 | Drug | Participants will receive AZD5462 orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under plasma concentration-time curve from time 0 to infinity (AUCinf) | The AUCinf of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. | Day 1 to Day 4 |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast) | The AUClast of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. | Day 1 to Day 4 |
| Time to reach maximum observed plasma concentration (tmax) | The tmax of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. | Day 1 to Day 4 |
| Maximum observed plasma concentration (Cmax) | The Cmax of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. | Day 1 to Day 4 |
| Terminal elimination rate constant (λz) | The λz of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. | Day 1 to Day 4 |
| Terminal elimination half-life (t½λz) | The t½λz of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Event (AEs) | The safety and tolerability of a single oral dose of AZD5462 in participants with renal impairment and healthy control participants matched at a group level will be assessed. | Day 1 to Day 7 |
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Main Inclusion Criteria:
Healthy matched participants (cohort2):
Participants With Renal Impairment:
Main Exclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Sofia | 1612 | Bulgaria |
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| Label | URL |
|---|---|
| Redacted CSR synopsis | View source |
| results posted on www.astrazenecaclinicaltrials.com | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes",indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Day 1 to Day 4 |
| Apparent total body clearance (CL/F) | The CL/F of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. | Day 1 to Day 4 |
| Non-renal clearance of drug from plasma (CLNR/F) | The CLNR/F of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. | Day 1 to Day 4 |
| Apparent volume of distribution based on the terminal phase (Vz/F) | The Vz/F of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. | Day 1 to Day 4 |
| Renal clearance of drug (CLR) | The CLR of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed. | Day 1 to Day 2 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |