A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function

This is an open-label (both study participant and investigator will know the name of the
assigned treatment), pharmacokinetic (the study of how drugs are absorbed in the body, how
they are distributed within the body, and how they are removed from the body over time)
study of canagliflozin in adult study participants with mild or moderate hepatic (liver)
impairment compared to study participants with normal hepatic function. Approximately 24
study participants who meet entry criteria for the study will be classified into 1 of 3
hepatic function groups: Group 1 (8 study participants with normal hepatic function), Group
2 (8 study participants with mild hepatic impairment) and Group 3 (8 study participants with
moderate hepatic impairment). The group allocation is based on the Child-Pugh score, an
assessment of 5 clinical measures that is used to characterize the degree of hepatic
impairment. At least 3 men and 3 women will be enrolled in each group and the 3 groups will
be balanced with respect to an average age and body weight. Study participants will be
required to stay overnight at the study center for 5 nights to receive study drug and have
study procedures and safety assessments performed. All study participants will be
administered a single 300-mg oral (by mouth) dose of canagliflozin after fasting (not eating
food) for a period of at least 10 hours. After study drug administration, study participants
will be provided with standardized meals (breakfast, lunch, and dinner). Blood and urine
samples for analyses of canagliflozin and metabolites (M7 and M5) will be collected from
study participants at specified time points up to 120 hours (blood) and 48 hours (urine)
after study drug administration. After discharge from the study center, study participants
will be required to return to the study center for 3 outpatient visits to have study
procedures and safety assessments performed. Study participants will be monitored for safety
during the study by evaluating adverse events reported and results from clinical laboratory
tests, 12-lead electrocardiograms (ECGs), vital sign measurements, and physical
examinations. On Day 1 of the study, a single 300 mg dose of canagliflozin will be orally
administered to study participants after a fasting period of at least 10 hours followed 10
minutes later by a standardized breakfast that must be eaten within 30 minutes. Study
participants are to remain standing or sitting for the first 4 hours after dosing. At 2
hours after dosing (but not earlier) all study participants must drink 1 glass of water;
drinking of water is allowed from then onwards.