A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
- Registration Number
- NCT06742762
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed 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.
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Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 21
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 AZD5004 Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions. Group 2 AZD5004 Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions. Group 3 (Optional) AZD5004 Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions.
- Primary Outcome Measures
Name Time Method Cmax Day 1 to Day 5 Maximum observed plasma concentration
AUCinf Day 1 to Day 5 Area under the concentration-time curve from zero to infinity
AUClast Day 1 to Day 5 Area under the concentration-time curve from zero to the last measurable concentration
- Secondary Outcome Measures
Name Time Method Tmax Day 1 to Day 5 Time to reach maximum observed plasma concentration
PK parameter t1/2λz Day 1 to Day 5 Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve
PK parameter CL/F Day 1 to Day 5 Apparent total body clearance of drug from plasma after extravascular administration
PK parameter CLNR/F Day 1 to Day 5 non-renal clearance of drug from plasma after oral administration
PK parameter Vz/F Day 1 to Day 5 Apparent volume of distribution during the terminal phase after extravascular administration
PK parameter CLr Day 1 to Day 5 Renal clearance of the drug from plasma
PK parameter Ae Day 1 to Day 5 Cumulative amount of unchanged drug excreted into the urine
fe Day 1 to Day 5 Fraction of the drug excreted into the urine
Trial Locations
- Locations (1)
Research Site
🇺🇸Orlando, Florida, United States