A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

NCT06661733 | Completed Phase 1 FDA Drug

• 2 other identifiers: D9090C000102024-514359-14-00
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AZD5462 in participants with impaired renal function.

Conditions

Renal Impairment

Keywords

Renal impairment

Outcome Measures

Primary Outcomes (10)

• 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.

  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

Secondary Outcomes (1)

• Number of participants with Adverse Event (AEs)

  Day 1 to Day 7

Study Arms (3)

Cohort 1

EXPERIMENTAL

Participants with severe renal impairment (eGFR ≥ 15 to \< 30 mL/min/1.73 m2, not requiring dialysis).

Drug: AZD5462

Cohort 2

EXPERIMENTAL

Participants who are healthy control (eGFR ≥ 90 mL/min/1.73 m2) matched at a group level to Cohort 1.

Drug: AZD5462

Cohort 3 (conditional)

EXPERIMENTAL

Participants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min/1.73 m2).

Drug: AZD5462

Interventions

AZD5462 DRUG

Participants will receive AZD5462 orally.

Cohort 1; Cohort 2; Cohort 3 (conditional)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Sofia, 1612, Bulgaria

Location

Related Links

• Redacted CSR synopsis
• results posted on www.astrazenecaclinicaltrials.com

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: November 18, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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
• Access Criteria: 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.

Locations

BU (1)