Effects of Single Oral Dose Dapagliflozin QT study
Study identifier:D1690C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Dapagliflozin, Moxifloxacin, Placebo to match moxifloxacin and dapagliflozin
Sex
Male
Actual Enrollment
36
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Jul 2007
Primary Completion Date: -
Study Completion Date: 01 Apr 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
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| 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 |
Contacts
Investigators
Principal Investigator
Glenn Carlson
AstraZeneca
