This is a study to compare AZD4831 pharmacokinetic (PK) parameters between participants with severe renal impairment and matched healthy volunteers following a single dose administration.
All participants will receive a single oral dose of AZD4831 under fasted conditions and will be involved in the study approximately 2 weeks after dosing and up to approximately 38 days from screening. Approximately 10 participants will be enrolled into each of the 2 cohorts parallelly and receive the study intervention to achieve 8 evaluable participants in each cohort. * Cohort 1: 10 participants with severe renal impairment (Estimated glomerular filtration rate \[eGFR\] of ≥15 to \<30 mL/min/1.73m\^2) * Cohort 2: 10 matched healthy volunteers with normal renal function (eGFR of ≥90 mL/min/1.73m\^2). The study will comprise of the following study periods: * Screening period (21 days): participants will be screened for eligibility. * Treatment period (3 days): participants will be admitted to the study centre in the evening of (Day -1) the day before administration of a single oral dose of AZD4831 (Day 1), and will be discharged after at least 24 h post-dose (Day 2). * Follow-up period (13±2 days): participants will attend 5 visits at the study centre for PK sampling and safety assessments on Days 3, 5, 8, 11 and 15.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Participants will receive a single dose of AZD4831 administered with 240 mL of water after an overnight fast of at least 10 hours.
Research Site
Sofia, Bulgaria
Maximum observed plasma concentration (Cmax)
Assessment of Cmax of a single oral dose of AZD4831 in participants with severe renal impairment compared with that in matched healthy volunteers.
Time frame: From Day 1 to Day 15
Time to reach maximum observed plasma concentration (tmax)
Assessment of tmax of a single oral dose of AZD4831 in participants with severe renal impairment compared with that in matched healthy volunteers.
Time frame: From Day 1 to Day 15
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)
Assessment of t½λz of a single oral dose of AZD4831 in participants with severe renal impairment compared with that in matched healthy volunteers.
Time frame: From Day 1 to Day 15
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Assessment of CL/F of a single oral dose of AZD4831 in participants with severe renal impairment compared with that in matched healthy volunteers.
Time frame: From Day 1 to Day 15
Apparent total non-renal body clearance of drug from plasma after extravascular administration (CLNR/F)
Assessment of CLNR/F of a single oral dose of AZD4831 in participants with severe renal impairment compared with that in matched healthy volunteers.
Time frame: From Day 1 to Day 15
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Assessment of Vz/F of a single oral dose of AZD4831 in participants with severe renal impairment compared with that in matched healthy volunteers.
Time frame: From Day 1 to Day 15
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Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)
Assessment of AUClast of a single oral dose of AZD4831 in participants with severe renal impairment compared with that in matched healthy volunteers.
Time frame: From Day 1 to Day 15
Area under plasma concentration-time curve from time zero to infinity (AUCinf)
Assessment of AUCinf of a single oral dose of AZD4831 in participants with severe renal impairment compared with that in matched healthy volunteers.
Time frame: From Day 1 to Day 15
Renal clearance of drug from plasma (CLR)
Assessment of CLR of a single oral dose of AZD4831 in participants with severe renal impairment compared with that in matched healthy volunteers.
Time frame: Days 1 and 2
Number of participants with adverse events
Assessment of the safety and tolerability of a single oral dose administration of AZD4831 in participants with severe renal impairment and their matched healthy volunteers.
Time frame: From Screening (Day -21 to Day -1) until Day 15 or Early Termination Visit