Effects of Single Oral Dose Dapagliflozin QT Study

Study Overview
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Dapagliflozin
* Drug: Moxifloxacin
* Drug: Placebo to match moxifloxacin and dapagliflozin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 mg single dose of dapagliflozin<br>20 mg dapagliflozin | Drug: Dapagliflozin<br>* 3 x 50 mg tablets, single oral dose<br>Drug: Dapagliflozin<br>* 2 x 10 mg capsules, single oral dose<br>Drug: Moxifloxacin<br>* Overencapsulated 400 mg capsule, single oral dose<br>* Other names: Avelox™;Drug: Placebo to match moxifloxacin and dapagliflozin<br>* Overencapsulated 400 mg capsule, single oral dose<br>|
| Experimental: 150 mg single dose of dapagliflozin2<br>150 mg dapagliflozin | Drug: Dapagliflozin<br>* 3 x 50 mg tablets, single oral dose<br>Drug: Dapagliflozin<br>* 2 x 10 mg capsules, single oral dose<br>Drug: Moxifloxacin<br>* Overencapsulated 400 mg capsule, single oral dose<br>* Other names: Avelox™;Drug: Placebo to match moxifloxacin and dapagliflozin<br>* Overencapsulated 400 mg capsule, single oral dose<br>|
| Active Comparator: 400 mg single dose of moxifloxacin<br>Moxifloxacin | Drug: Dapagliflozin<br>* 3 x 50 mg tablets, single oral dose<br>Drug: Dapagliflozin<br>* 2 x 10 mg capsules, single oral dose<br>Drug: Moxifloxacin<br>* Overencapsulated 400 mg capsule, single oral dose<br>* Other names: Avelox™;Drug: Placebo to match moxifloxacin and dapagliflozin<br>* Overencapsulated 400 mg capsule, single oral dose<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Dapagliflozin<br>* 3 x 50 mg tablets, single oral dose<br>Drug: Dapagliflozin<br>* 2 x 10 mg capsules, single oral dose<br>Drug: Moxifloxacin<br>* Overencapsulated 400 mg capsule, single oral dose<br>* Other names: Avelox™;Drug: Placebo to match moxifloxacin and dapagliflozin<br>* Overencapsulated 400 mg capsule, single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electronic measures of heart beats |  | ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers |  | At scheduled times during the 3 day periods following dosing during each of the 4 study periods | 
| Safety and tolerability of dapagliflozin |  | Screening through completion of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QT, Healthy volunteers