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

NCT06742762

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Renal Impairment

Interventions: AZD5004

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (3)

Miami Lakes, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States