A Study of 28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Volunteers

Part of paid clinical trials in La Jolla, California.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01173549
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin/Placebo Placebo/Canagliflozin — DRUG
    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).
  • no intervention — OTHER
    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.

Study Details

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

Key Dates

Start date
Nov 30, 2010
Status verified
Dec 2011
Completion
Sep 30, 2011

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Experimental: 001
    no intervention 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.
  • Experimental: 002
    Canagliflozin/Placebo Placebo/Canagliflozin 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).

Primary Outcome Measure

The amount of ingested glucose that is absorbed in systemic circulation [ Time Frame: During the first 1 and 2 hours after a standard mixed meal ]

Locations (1)

FacilityCityStateZIPSite coordinators
-La JollaCalifornia--

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