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

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.

Conditions

Renal Impairment

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Renal Impairment
Intervention / Treatment

-

Contacts and Locations

Miami Lakes

Research Site, Miami Lakes, Florida, United States, 33014

Orlando

Research Site, Orlando, Florida, United States, 32808

Orlando

Research Site, Orlando, Florida, United States, 32809

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2025-06-23