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

Phase 1
Not yet recruiting
Conditions
Interventions
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
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.

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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 1AZD5004Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions.
Group 2AZD5004Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions.
Group 3 (Optional)AZD5004Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions.
Primary Outcome Measures
NameTimeMethod
CmaxDay 1 to Day 5

Maximum observed plasma concentration

AUCinfDay 1 to Day 5

Area under the concentration-time curve from zero to infinity

AUClastDay 1 to Day 5

Area under the concentration-time curve from zero to the last measurable concentration

Secondary Outcome Measures
NameTimeMethod
TmaxDay 1 to Day 5

Time to reach maximum observed plasma concentration

PK parameter t1/2λzDay 1 to Day 5

Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve

PK parameter CL/FDay 1 to Day 5

Apparent total body clearance of drug from plasma after extravascular administration

PK parameter CLNR/FDay 1 to Day 5

non-renal clearance of drug from plasma after oral administration

PK parameter Vz/FDay 1 to Day 5

Apparent volume of distribution during the terminal phase after extravascular administration

PK parameter CLrDay 1 to Day 5

Renal clearance of the drug from plasma

PK parameter AeDay 1 to Day 5

Cumulative amount of unchanged drug excreted into the urine

feDay 1 to Day 5

Fraction of the drug excreted into the urine

Trial Locations

Locations (1)

Research Site

🇺🇸

Orlando, Florida, United States

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