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

NCT06742762 | Completed Phase 1 FDA Drug

• 1 other identifier: D7260C00006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Renal Impairment

Keywords

Renal Impairment; Healthy participants; AZD5004; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Tmax

  Day 1 to Day 5

• PK parameter t1/2λz

  Day 1 to Day 5

• PK parameter CL/F

  Day 1 to Day 5

• PK parameter CLNR/F

  Day 1 to Day 5

• PK parameter Vz/F

  Day 1 to Day 5

Other Outcomes (3)

• Number of participants with adverse events (AEs)

  Day 1 to Day 10

• Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings

  Day 1 to Day 5

• Number of participants with abnormal laboratory tests results

  Day 1 to Day 5

Study Arms (3)

Group 1

EXPERIMENTAL

Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions.

Drug: AZD5004

Group 2

EXPERIMENTAL

Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions.

Drug: AZD5004

Group 3 (Optional)

EXPERIMENTAL

Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions.

Drug: AZD5004

Interventions

AZD5004 DRUG

Dose 1

Also known as: ECC5004, Dose 1

Group 1; Group 2; Group 3 (Optional)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Miami Lakes, Florida, 33014, United States

Location

Research Site

Orlando, Florida, 32808, United States

Location

Research Site

Orlando, Florida, 32809, United States

Location

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

Model Details: Up to three groups (two renal impairment groups and controls with normal renal function) will be enrolled into this study. All subjects will receive the study intervention: Group 1 will enroll 7 participants with severe renal impairment Group 2 will enroll \~7 participants with normal renal function matched by sex, age, and body weight Group 3 (optional) will enroll 7 participants with moderate renal impairment

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: December 17, 2024
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• 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
• 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

Locations

US (3)