Investigating how renal impairment affects the drug AZD5004

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

This study is testing how well the drug AZD5004 works and is tolerated in people with different levels of kidney problems compared to those with healthy kidneys.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 3 sites (Miami Lakes, Florida and 2 other locations)
• Trial ID: NCT06742762 on ClinicalTrials.gov

What this trial studies

This Phase I study is designed to evaluate the pharmacokinetics, safety, and tolerability of AZD5004 in participants with varying degrees of renal impairment compared to those with normal renal function. The study will involve a multicenter, single-dose, open-label approach, where participants will be grouped based on their estimated glomerular filtration rate (eGFR). Specifically, it will include individuals with severe renal impairment, moderate renal impairment, and healthy controls matched by sex, age, and body weight. The aim is to gather data that could inform dosing and safety considerations for patients with renal issues.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with severe or moderate renal impairment or those with normal renal function.

Not a fit: Patients with poorly controlled diabetes, unstable systemic diseases, or significant psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective dosing guidelines for patients with renal impairment who require treatment with AZD5004.

How similar studies have performed: Other studies examining pharmacokinetics in renal impairment have shown promising results, indicating that this approach is supported by prior research.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Miami Lakes, Florida and 2 other locations

• Research Site — Miami Lakes, Florida, United States (Recruiting)
• Research Site — Orlando, Florida, United States (Recruiting)
• Research Site — Orlando, Florida, United States (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Renal Impairment; Healthy participants; AZD5004; Pharmacokinetics; Safety