Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

NCT06813781 | Completed Phase 1 FDA Drug

• 1 other identifier: D7260C00011
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

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 mild, moderate, and severe hepatic impairment compared with participants with normal hepatic function.

Conditions

Hepatic Impairment

Keywords

Hepatic Impairment; Healthy participants; AZD5004; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (3)

• AUCinf

  Area under plasma concentration-time curve from zero to infinity

  Day 1 to Day 6

• AUClast

  Area under plasma concentration-time curve from time zero to the last measurable concentration

  Day 1 to Day 6

• Cmax

  Maximum observed plasma concentration

  Day 1 to Day 6

Secondary Outcomes (8)

• Tmax

  Day 1 to Day 6

• PK parameters (t1/2λz)

  Day 1 to Day 6

• PK parameters CL/F

  Day 1 to Day 6

• PK parameters CLNR/F

  Day 1 to Day 6

• PK parameter Vz/F

  Day 1 to Day 6

Other Outcomes (8)

• Number of participants with adverse events (AEs)

  Day 1 to Day 10

• Participants with abnormal blood pressure

  Day 1 to Day 6

• Number of participants with abnormal laboratory tests results

  Day 1 to Day 6

Study Arms (4)

Group 1

EXPERIMENTAL

A single oral dose of AZD5004 under fasted conditions.

Drug: AZD5004

Group 2

EXPERIMENTAL

A single oral dose of AZD5004 under fasted conditions.

Drug: AZD5004

Group 3

EXPERIMENTAL

A single oral dose of AZD5004 under fasted conditions.

Drug: AZD5004

Group 4

EXPERIMENTAL

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; Group 4

Eligibility Criteria

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

You may qualify if:

• For ALL participants:
• Adults 18-80 years of age
• Weight ≥50kg and BMI between ≥18 to ≤40 kg/m2 For participants with normal hepatic function:
• Participant must be stable on a concomitant medication and/or treatment regimen for at least 2 weeks prior to screening
• For Healthy Controls:
• Participant must be medically healthy with no significant findings on medical evaluation at screening to include but not limited to an eGFR \>90 ml/min/1.73 m2
• For participants with hepatic impairment:
• Group 1 (mild) must have an Child-Pugh score of 5 or 6, Group 2 (moderate) must have a Child-Pugh score of 7 to 9, Group 3 (severe) must have a Child-Pugh score of 10 to 15.
• Participant must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment (eg, no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study screening

You may not qualify if:

• For ALL participants:
• Poorly controlled diabetes mellitus (A1C \>10% at screening).
• Unwillingness to use adequate contraception
• Uncontrolled hypertension or hypotension
• Presence of unstable systemic disease or psychologic conditions.
• Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG.
• Specific For Healthy Controls:
• Positive screening for HIV, Hepatitis B, or Hepatitis C -
• Any clinically significant disease or disorder to include but not limited to acute or chronic liver disease
• Specific For Hepatically Impaired Participants:
• eGFR \<60 ml/min/1.73 m2
• Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment to include rising LFTs, paracentesis at less than 4 week intervals, oesophageal banding within the last 3 months, or treatment for GI bleeding within the last 6 months
• Presence of a hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.

Sponsors & Collaborators

• AstraZeneca: lead
• Fortrea Clinical Research Unit Inc.: collaborator

Study Sites (5)

Research Site

Lake Forest, California, 92630, United States

Location

Research Site

Rialto, California, 92377, United States

Location

Research Site

Miami Lakes, Florida, 33014, United States

Location

Research Site

Orlando, Florida, 32809, United States

Location

Research Site

San Antonio, Texas, 78215, United States

Location

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 four groups (three hepatic impairment groups and controls with normal hepatic function) will be enrolled into this study. All participants will receive the study intervention: * Cohort 1 will enroll 8 participants with mild hepatic impairment * Cohort 2 will enroll 8 participants with moderate hepatic impairment * Cohort 3 will enroll 6-8 participants with severe hepatic impairment * Cohort 4 will enroll \~8 participants with normal hepatic function matched by sex, age, and body weight

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: February 7, 2025
• Study Start: December 19, 2024
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

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 (5)