A Pharmacokinetic and Bioavailability Study of 28431754 (Canagliflozin) in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the absolute oral bioavailability (how fast and how
      much study drug is absorbed in the body) of a single 300-mg oral dose of canagliflozin in
      healthy male volunteers.
    

Detailed description: 
      This is an open-label (the patient will know the identity of the treatment they receive),
      single-dose, single-center study to evaluate the absolute oral bioavailability (the rate and
      extent at which the drug is absorbed in the body and reaches blood circulation) of a 300-mg
      tablet of canagliflozin. Approximately 9 healthy men (referred to as healthy male volunteers)
      will receive a single 300-mg tablet of canagliflozin with an 8 ounce glass of water followed
      105 minutes later by a 15 minute intravenous (iv) infusion (administration directly in the
      vein) of a very small dose (ie, 10 micrograms [mcg]) of canagliflozin that has been combined
      with a radioactive carbon isotope referred to as 14C canagliflozin. The radiolabelled 10 mcg
      dose of canagliflozin will act as a tracer to measure the total amount of canagliflozin that
      is absorbed and metabolized in the body. After dosing, blood, urine and feces samples will be
      collected for pharmacokinetic and safety evaluations at specified timepoints for up to 72
      hours. The primary outcome measure in the study is to determine the absolute bioavailability
      of a single 300 mg dose of canagliflozin by estimation of protocol-specified standard plasma
      pharmacokinetic parameters (parameters that measure the absorption, distribution, metabolism,
      and elimination of drug by the body) from blood samples obtained during the study. During the
      study, the safety of a single oral 300-mg dose of canagliflozin administered together with a
      single iv 10-mcg infusion dose of 14C-canagliflozin will be evaluated by monitoring adverse
      events and findings from clinical laboratory test values, physical examination results, 12
      lead ECGs and vital signs measurements reported. On Day 1, each healthy volunteer will take a
      single 300-mg canagliflozin tablet orally (by mouth) with 8 ounces of water in the morning
      followed by a 15-minute intravenous infusion of 10 mcg 14C-canagliflozin (200 nCi)
      (equivalent to 0.666 mcg/mL of canagliflozin). Healthy volunteers will fast at least 10 hours
      before dosing and until at least 4 hours after oral administration and will not be allowed to
      drink water from 2 hours before and up to 4 hours after study drug administration.
    

Intervention name(s): Canagliflozin
Intervention type(s): Drug
Intervention description(s): On Day 1, all patients will receive a single 300-mg tablet of canagliflozin with 8 ounces of water followed 105 minutes later by a 15-minute intravenous infusion dose (15 mL) of 10 mcg of 14C-canagliflozin (200 nCi).
Intervention MeSH terms: Canagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Canagliflozin; Pharmacokinetic; Bioavailability