A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: AZD5004

Detailed Description

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

Participants will be assigned to the following groups based on eGFR determined at screening by a local laboratory using serum creatinine:

Group 1: Participants with severe renal impairment (eGFR < 30 mL/min), not on dialysis.

Group 2: Participants with normal renal function (eGFR of ≥ 90 mL/min) matched by sex, age, and body weight on a group level to the impaired participants.

Group 3 (optional): Participants with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Research Site
    • Orlando, Florida, United States, 32809
      • Research Site
    • Orlando, Florida, United States, 32808
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults 18-80 years of age
• Weight >50kg and BMI between 18-40 kg/m2

For participants with normal renal function:

-Participant must be medically healthy with no significant findings on medical evaluation and an eGFR ≥90 ml/min at screening.

For participants with renal impairment:

Group 1 (severe) must have an eGFR <30 ml/min and Group 3 (moderate) must have an eGFR 30 to <60 ml/min based on CKD-EPI calculations for at least 6 months prior to enrollment.

Exclusion Criteria:

• Poorly controlled diabetes mellitus (A1C >10% at screening or recent history of diabetic ketoacidosis or symptomatic hypoglycemia).
• Unwillingness to use adequate contraception
• Uncontrolled hypertension or hypotension.
• Positive screening for HIV, Hepatitis B, or Hepatitis C
• Presence of unstable systemic disease or psychologic conditions. Abnormal laboratory values to include but not limited to liver function tests (thresholds differ for renal impairment and health controls)
• Any change in baseline medication within 2 weeks of planned study initiation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions.	Drug: AZD5004; Dose 1; Other Names: Dose 1; ECC5004
Experimental: Group 2; Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions.	Drug: AZD5004; Dose 1; Other Names: Dose 1; ECC5004
Experimental: Group 3 (Optional); Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions.	Drug: AZD5004; Dose 1; Other Names: Dose 1; ECC5004

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	Area under the concentration-time curve from zero to infinity	Day 1 to Day 5
AUClast	Area under the concentration-time curve from zero to the last measurable concentration	Day 1 to Day 5
Cmax	Maximum observed plasma concentration	Day 1 to Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to reach maximum observed plasma concentration	Day 1 to Day 5
PK parameter t1/2λz	Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve	Day 1 to Day 5
PK parameter CL/F	Apparent total body clearance of drug from plasma after extravascular administration	Day 1 to Day 5
PK parameter CLNR/F	non-renal clearance of drug from plasma after oral administration	Day 1 to Day 5
PK parameter Vz/F	Apparent volume of distribution during the terminal phase after extravascular administration	Day 1 to Day 5
PK parameter CLr	Renal clearance of the drug from plasma	Day 1 to Day 5
PK parameter Ae	Cumulative amount of unchanged drug excreted into the urine	Day 1 to Day 5
fe	Fraction of the drug excreted into the urine	Day 1 to Day 5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	To assess the safety and tolerability of a single oral dose of AZD5004 for participants with severe and moderate (optional) renal impairment and those with normal renal function	Day 1 to Day 10
Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings	To assess the safety and tolerability of a single oral dose of AZD5004 for participants with severe and moderate (optional) renal impairment and those with normal renal function	Day 1 to Day 5
Number of participants with abnormal laboratory tests results	To assess the safety and tolerability of a single oral dose of AZD5004 for participants with severe and moderate (optional) renal impairment and those with normal renal function	Day 1 to Day 5

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Actual): April 20, 2025
• Study Completion (Actual): April 20, 2025

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Healthy participants; Renal Impairment; AZD5004
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency
• Other Study ID Numbers: D7260C00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. 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 shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No