Novartis Pharmaceuticals
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).
Inclusion Criteria: All participants (Group 1, 2 \& 3) * Male and female participants 18 to 80 years of age (inclusive). * Weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 42.0 kg/m2, inclusive, at Screening. Participants with moderate and severe RI (Group 1 \& 2) * Have impaired renal function as determined by the mean eGFR calculated using the CKD EPI Creatinine - Cystatin C equation (2021) (refer to Section 8.5.1 for equation), and fall into one of the following groups: * Group 1: moderate RI; eGFR 30 to 60 mL/min, inclusive. * Group 2: severe RI; eGFR \<30 mL…
PKN605 orally as a tablet under fasted conditions
Arctuva estimate
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