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, 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
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
Loading...
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 |
Contacts
Investigators
Principal Investigator
Glenn Carlson
AstraZeneca
