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

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 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
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

Resource links provided by NLM:

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

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:	April 2008

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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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:

No personal or family history of significant heart problems
No use of over the counter medications within 7 days of the study
No use of prescription medicaiton within 1 month of the study

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

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00688493 History of Changes
Other Study ID Numbers:	D1690C00001
Study First Received:	May 30, 2008
Last Updated:	March 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

QT
Healthy volunteers

Additional relevant MeSH terms:

Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined

Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013