A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function
Condition: Healthy; Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the concentration of canagliflozin in blood and
      urine samples after the administration of canagliflozin to study participants with mild or
      moderate hepatic (liver) impairment compared with study participants with normal hepatic
      function.
    

Detailed description: 
      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.
    

Intervention name(s): Canagliflozin
Intervention type(s): Drug
Intervention description(s): One 300-mg dose of canagliflozin on Day 1
Intervention MeSH terms: Canagliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Canagliflozin; JNJ-28431754; Liver diseases; Hepatic impairment; Pharmacokinetic; Normal hepatic function