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

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT06742762

Run by

AstraZeneca

People needed

16

Starts

2024-12-17

Expected to finish

2025-04-20

Last updated by the study team

2025-06-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Research Site — Miami Lakes, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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