This study will evaluate the pharmacokinetics (PK), safety, and tolerability of single subcutaneous dose of AZD6234 with end stage renal disease, severe, and possibly moderate and mild renal impairment in comparison to a matched healthy control group.
This Phase I multicentre, single-dose, non-randomised, open-label, parallel-group study aims to examine the pharmacokinetics, safety, and tolerability of AZD6234 in both male and female participants. Participants include those with end-stage renal disease (ESRD) on intermittent haemodialysis (HD), severe renal impairment not on dialysis, and optional groups for moderate and mild renal impairment. These are compared to participants with normal renal function. All participants are grouped based on body surface area-adjusted estimated glomerular filtration rate (eGFR), and those with normal renal function are matched at a group level by sex, age, and body mass index (BMI) to the participants with impaired renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Dose 1
Research Site
Lake Forest, California, United States
Research Site
Orlando, Florida, United States
Research Site
Orlando, Florida, United States
AUClast
Area under plasma concentration-time curve from time zero to the last measurable concentration
Time frame: Day 1 to Day 36
AUCinf
Area under plasma concentration-time curve from zero to infinity
Time frame: Day 1 to Day 36
Cmax
Maximum observed plasma concentration
Time frame: Day 1 to Day 36
Tmax
Time to reach maximum observed plasma concentration
Time frame: Day 1 to Day 36
PK parameter (t1/2λz)
Terminal elimination half-life
Time frame: Day 1 to Day 36
PK parameter (CL/F)
Apparent plasma clearance
Time frame: Day 1 to Day 36
PK parameter (Vz/F)
Apparent volume of distribution during the terminal phase
Time frame: Day 1 to Day 36
Number of participants with adverse events (AEs)
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Time frame: Day 1 to Day 54
Number of participants with abnormal vital signs
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To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Time frame: Day 1 to Day 54
Number of participants with abnormal ECGs
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Time frame: Day 1 to Day 54
Number of participants with abnormal physical examination findings
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Time frame: Day 1 to Day 54
Number of participants with abnormal laboratory test results
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Time frame: Day 1 to Day 54
Number of participants with confirmed positive anti-drug antibody testing
Prevalence and incidence of ADAs to AZD6234 ADA titre
Time frame: Day 1 to Day 54
Number of participants with serious adverse events (SAEs)
To assess the safety and tolerability of a single subcutaneous dose of AZD6234 in participants with end stage renal disease, severe, moderate (optional), and mild (optional) renal impairment and those with normal renal function.
Time frame: Day 1 to Day 54