COMPLETED

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

Conditions

Hepatic Impairment Healthy participants AZD5004 Pharmacokinetics Safety

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-12-19

Study Completion:2025-10-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06813781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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	* 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. * 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.

Inclusion Criteria

Exclusion Criteria

* 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
* 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

* 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.
* 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.

Contacts and Locations

Study Locations (Sites)

Research Site

Lake Forest, California, 92630

United States

Research Site

Rialto, California, 92377

United States

Research Site

Miami Lakes, Florida, 33014

United States

Research Site

Orlando, Florida, 32809

United States

Research Site

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-19

Study Completion Date2025-10-02

Study Record Updates

Study Start Date2024-12-19

Study Completion Date2025-10-02

Terms related to this study

Keywords Provided by Researchers

Hepatic Impairment
Healthy participants
AZD5004
Pharmacokinetics
Safety

Additional Relevant MeSH Terms

Hepatic Impairment