Study identifier:D1690C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A double-blind, randomized, four-period crossover study to assess the effects of single oral dose Dapagliflozin administration on QTc interval compared to placebo, using AVELOX™ (moxifloxacin) as a positive control, in healthy male volunteers age 18 to 45 years
Healthy
Phase 1
Yes
Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin, Moxifloxacin, Moxifloxacin, Moxifloxacin, Moxifloxacin, Placebo to match moxifloxacin and dapagliflozin, Placebo to match moxifloxacin and dapagliflozin, Placebo to match moxifloxacin and dapagliflozin, Placebo to match moxifloxacin and dapagliflozin
Male
36
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Bristol-Myers Squibb
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 20 mg single dose of dapagliflozin 20 mg dapagliflozin | Drug: Dapagliflozin 3 x 50 mg tablets, single oral dose Drug: Dapagliflozin 2 x 10 mg capsules, single oral dose Drug: Moxifloxacin Overencapsulated 400 mg capsule, single oral dose Other Name: Avelox™ Drug: Placebo to match moxifloxacin and dapagliflozin Overencapsulated 400 mg capsule, single oral dose |
Experimental: 150 mg single dose of dapagliflozin2 150 mg dapagliflozin | Drug: Dapagliflozin 3 x 50 mg tablets, single oral dose Drug: Dapagliflozin 2 x 10 mg capsules, single oral dose Drug: Moxifloxacin Overencapsulated 400 mg capsule, single oral dose Other Name: Avelox™ Drug: Placebo to match moxifloxacin and dapagliflozin Overencapsulated 400 mg capsule, single oral dose |
Active Comparator: 400 mg single dose of moxifloxacin Moxifloxacin | Drug: Dapagliflozin 3 x 50 mg tablets, single oral dose Drug: Dapagliflozin 2 x 10 mg capsules, single oral dose Drug: Moxifloxacin Overencapsulated 400 mg capsule, single oral dose Other Name: Avelox™ Drug: Placebo to match moxifloxacin and dapagliflozin Overencapsulated 400 mg capsule, single oral dose |
Placebo Comparator: Placebo Placebo | Drug: Dapagliflozin 3 x 50 mg tablets, single oral dose Drug: Dapagliflozin 2 x 10 mg capsules, single oral dose Drug: Moxifloxacin Overencapsulated 400 mg capsule, single oral dose Other Name: Avelox™ Drug: Placebo to match moxifloxacin and dapagliflozin Overencapsulated 400 mg capsule, single oral dose |