Effects of Single Oral Dose Dapagliflozin QT Study - Full Text View

Sponsors and Collaborators:	AstraZeneca Bristol-Myers Squibb
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00688493

Purpose

The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males

Condition	Intervention	Phase
Healthy	Drug: Dapagliflozin Drug: Moxifloxacin Drug: Placebo to match moxifloxacin and dapagliflozin	Phase I

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Electronic measures of heart beats [ Time Frame: ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers [ Time Frame: At scheduled times during the 3 day periods following dosing during each of the 4 study periods ] [ Designated as safety issue: No ]
Safety and tolerability of dapagliflozin [ Time Frame: Screening through completion of the study ] [ Designated as safety issue: Yes ]

Enrollment:	36
Study Start Date:	July 2007
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
20 mg single dose of dapagliflozin: Experimental 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 Drug: Placebo to match moxifloxacin and dapagliflozin Overencapsulated 400 mg capsule, single oral dose
150 mg single dose of dapagliflozin2: Experimental 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 Drug: Placebo to match moxifloxacin and dapagliflozin Overencapsulated 400 mg capsule, single oral dose
400 mg single dose of moxifloxacin: Active Comparator 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 Drug: Placebo to match moxifloxacin and dapagliflozin Overencapsulated 400 mg capsule, single oral dose
Placebo: Placebo Comparator 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 Drug: Placebo to match moxifloxacin and dapagliflozin Overencapsulated 400 mg capsule, single oral dose

Eligibility

Criteria

Inclusion Criteria:

Healthy males age 18 to 45 years of age, who are not currently taking any medications
Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688493

Locations

United States, Maryland
Research Site
Baltimore, Maryland, United States

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Study Director:	Glenn Carlson, MD	AstraZeneca
Principal Investigator:	Ronald Goldwater, MD	Parexel International

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Shamik Parikh, MD, Medical Science Director, Dapagliflozin )
Study ID Numbers:	D1690C00001
Study First Received:	May 30, 2008
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00688493
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

QT
Healthy volunteers

Study placed in the following topic categories:

Moxifloxacin
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009