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