A Study of 28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of canagliflozin on gastrointestinal
      glucose absorption in healthy volunteers.
    

Detailed description: 
      This is a single center study that will be conducted in two Parts (Part 1 and Part 2) to
      evaluate the effect of a single-dose of canagliflozin on the absorption of glucose in healthy
      volunteers. Part 1 is a pilot (small) study where responses to key pharmocodynamic (PD)
      parameters (ie, specific tests on blood samples to evaluate effects of no treatment on the
      body) will be measured to confirm the study design and number of volunteers planned for Part
      2. Part 2 is the main study where volunteers will be randomized (assigned to study drug or
      placebo by chance) to receive double-blind (neither the volunteer or study physician will
      know the identity of the treatment assigned) treatment with canagliflozin or placebo
      (treatment identical in appearance to canagliflozin but contains no active drug) to evaluate
      the effect of canagliflozin compared to placebo on gastrointestinal glucose absorption using
      a radiolabeled glucose tracer approach (ie, where a radioactive substance is combined with
      glucose allowing the movement of glucose in the body to be traced or detected). Blood and
      urine samples will be collected from volunteers at pre-defined times during the study for PD
      analysis. Safety will be monitored during the study by evaluating adverse events and results
      from clinical laboratory tests, vital signs measurements, electrocardiograms (ECGs), and
      physical examinations performed. Volunteers in Part 1 will receive 240 ml of water 10 minutes
      before starting of the MMTT in each period (Periods 1 and 2). Volunteers in Part 2 will
      receive study drug 20 minutes prior to starting of the MMTT in treatment sequence 1 (a single
      300-mg dose of canagliflozin in Period 1 followed by matching placebo in Period 2) or in
      treatment Sequence 2 (matching placebo in Period 1 followed by a single 300-mg dose of
      canagliflozin in Period 2). Periods 1 and 2 will be separated by 7 to 21 days.
    

Intervention name(s): Canagliflozin/Placebo Placebo/Canagliflozin; no intervention
Intervention type(s): Drug; Other
Intervention description(s): Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2).; Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days.
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Canagliflozin; Pharmacodynamic; Glucose absorption; Glucose metabolism