COMPLETED

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

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 severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

Official Title

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

Quick Facts

Study Start:2024-12-17
Study Completion:2025-04-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06742762

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 CriteriaExclusion Criteria
  1. * Adults 18-80 years of age
  2. * Weight \>50kg and BMI between 18-40 kg/m2
  1. * Poorly controlled diabetes mellitus (A1C \>10% at screening or recent history of diabetic ketoacidosis or symptomatic hypoglycemia).
  2. * Unwillingness to use adequate contraception
  3. * Uncontrolled hypertension or hypotension.
  4. * Positive screening for HIV, Hepatitis B, or Hepatitis C
  5. * 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)
  6. * Any change in baseline medication within 2 weeks of planned study initiation.

Contacts and Locations

Study Locations (Sites)

Research Site
Miami Lakes, Florida, 33014
United States
Research Site
Orlando, Florida, 32808
United States
Research Site
Orlando, Florida, 32809
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 Date2024-12-17
Study Completion Date2025-04-20

Study Record Updates

Study Start Date2024-12-17
Study Completion Date2025-04-20

Terms related to this study

Keywords Provided by Researchers

  • Renal Impairment
  • Healthy participants
  • AZD5004
  • Pharmacokinetics
  • Safety

Additional Relevant MeSH Terms

  • Renal Impairment