The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
This is a Phase 1, single-dose, open-label, non-randomized renal impairment study to assess the PK after a single administration of PKN605 in participants with moderate (Group 1) and severe (Group 2) renal impairment and matched healthy participants with normal renal function (Group 3).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
PKN605 orally as a tablet under fasted conditions
Primary plasma PK parameters: Cmax
Cmax: The maximum (peak) observed plasma concentration
Time frame: Up to 5 days
Primary plasma PK parameters: AUClast
AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast)
Time frame: Up to 5 days
Primary plasma PK parameters: AUCinf
AUCinf: The AUC from time zero to infinity
Time frame: Up to 5 days
Secondary plasma PK parameters: Tmax
Tmax: The time to reach maximum (peak) plasma concentration
Time frame: Up to 5 days
Secondary plasma PK parameters: AUC0-t
AUC0-t: The AUC from time zero to time t
Time frame: Up to 5 days
Secondary plasma PK parameters: T1/2
T1/2: The elimination half-life associated with the terminal slope (λz) of a semi-logarithmic concentration-time curve (time)
Time frame: Up to 5 days
Secondary plasma PK parameters: Tlast
Tlast: The last measurable concentration sampling time
Time frame: Up to 5 days
Secondary plasma PK parameters: CL/F
CL/F: The apparent total body clearance of drug from the plasma
Time frame: Up to 5 days
Secondary plasma PK parameters: Vz/F
Vz/F: The apparent volume of distribution during terminal phase (associated with λz)
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Time frame: Up to 5 days
Number of participants with Adverse Events (AEs)
Number of participants with Adverse Events (AEs), including abnormal vital signs, electrocardiograms (ECGs) and safety laboratory parameters
Time frame: Up to 35 days