The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AZD5462 in participants with impaired renal function.
This is a Phase I, single dose, non-randomised, open-label, parallel group study to assess the PK, safety, and tolerability of AZD5462 in male and female participants (females of non-childbearing potential) with renal impairment. This study consists of 3 cohorts: 1. Cohort 1: Participants with severe renal impairment (eGFR ≥ 15 to \< 30mL/min/1.73 m2, not requiring dialysis). 2. Cohort 2: Participants who are healthy control (eGFR ≥ 90 mL/min/1.73 m2) matched at a group level to Cohort 1. 3. Cohort 3 (conditional): Participants with moderate renal impairment (eGFR ≥ 30 to \< 60mL/min/1.73 m2). This study comprises of three periods: * Screening period: 21 days * In-patient (Treatment) period: 4 days * Out-patient visit: On Day 4, participants will return to the study site to undergo safety assessments and provide blood samples 72 hours post-dose. Participants may stay at the study site for this visit if preferred. * Follow-up visit: On Day 7 (± 2), participants will return to the study site for safety assessments. The duration of the study for an individual participant from the Screening Visit to the Follow-up Visit will be approximately 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants will receive AZD5462 orally.
Research Site
Sofia, Bulgaria
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The AUCinf of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 4
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The AUClast of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 4
Time to reach maximum observed plasma concentration (tmax)
The tmax of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 4
Maximum observed plasma concentration (Cmax)
The Cmax of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 4
Terminal elimination rate constant (λz)
The λz of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 4
Terminal elimination half-life (t½λz)
The t½λz of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 4
Apparent total body clearance (CL/F)
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The CL/F of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 4
Non-renal clearance of drug from plasma (CLNR/F)
The CLNR/F of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 4
Apparent volume of distribution based on the terminal phase (Vz/F)
The Vz/F of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 4
Renal clearance of drug (CLR)
The CLR of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 2
Number of participants with Adverse Event (AEs)
The safety and tolerability of a single oral dose of AZD5462 in participants with renal impairment and healthy control participants matched at a group level will be assessed.
Time frame: Day 1 to Day 7