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

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.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. Participants will be assigned to the following groups based on eGFR determined at screening by a local laboratory using serum creatinine: Group 1: Participants with severe renal impairment (eGFR \< 30 mL/min), not on dialysis. Group 2: Participants with normal renal function (eGFR of ≥ 90 mL/min) matched by sex, age, and body weight on a group level to

Trial Eligibility

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.

Study Info

Interventions

Locations Recruiting

Interested in joining this trial?

Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.