Effects of Single Oral Dose Dapagliflozin QT Study

NCT ID: NCT00688493

Last Updated: 2012-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-04-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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20 mg single dose of dapagliflozin

20 mg dapagliflozin

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

3 x 50 mg tablets, single oral dose

Dapagliflozin

Intervention Type DRUG

2 x 10 mg capsules, single oral dose

Moxifloxacin

Intervention Type DRUG

Overencapsulated 400 mg capsule, single oral dose

Placebo to match moxifloxacin and dapagliflozin

Intervention Type DRUG

Overencapsulated 400 mg capsule, single oral dose

150 mg single dose of dapagliflozin2

150 mg dapagliflozin

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

3 x 50 mg tablets, single oral dose

Dapagliflozin

Intervention Type DRUG

2 x 10 mg capsules, single oral dose

Moxifloxacin

Intervention Type DRUG

Overencapsulated 400 mg capsule, single oral dose

Placebo to match moxifloxacin and dapagliflozin

Intervention Type DRUG

Overencapsulated 400 mg capsule, single oral dose

400 mg single dose of moxifloxacin

Moxifloxacin

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

3 x 50 mg tablets, single oral dose

Dapagliflozin

Intervention Type DRUG

2 x 10 mg capsules, single oral dose

Moxifloxacin

Intervention Type DRUG

Overencapsulated 400 mg capsule, single oral dose

Placebo to match moxifloxacin and dapagliflozin

Intervention Type DRUG

Overencapsulated 400 mg capsule, single oral dose

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Dapagliflozin

Intervention Type DRUG

3 x 50 mg tablets, single oral dose

Dapagliflozin

Intervention Type DRUG

2 x 10 mg capsules, single oral dose

Moxifloxacin

Intervention Type DRUG

Overencapsulated 400 mg capsule, single oral dose

Placebo to match moxifloxacin and dapagliflozin

Intervention Type DRUG

Overencapsulated 400 mg capsule, single oral dose

Interventions

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Dapagliflozin

3 x 50 mg tablets, single oral dose

Intervention Type DRUG

Dapagliflozin

2 x 10 mg capsules, single oral dose

Intervention Type DRUG

Moxifloxacin

Overencapsulated 400 mg capsule, single oral dose

Intervention Type DRUG

Placebo to match moxifloxacin and dapagliflozin

Overencapsulated 400 mg capsule, single oral dose

Intervention Type DRUG

Other Intervention Names

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Avelox™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn Carlson, MD

Role: STUDY_DIRECTOR

AstraZeneca

Ronald Goldwater, MD

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

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Research Site

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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D1690C00001

Identifier Type: -

Identifier Source: org_study_id

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