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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00688493 |
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Date of registration:
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30/05/2008 |
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Primary sponsor: |
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Public title:
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Effects of Single Oral Dose Dapagliflozin QT Study
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Scientific 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 |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00688493 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Glenn Carlson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Name:
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Ronald Goldwater, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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PAREXEL International |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Dapagliflozin
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Drug: Moxifloxacin
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Drug: Placebo to match moxifloxacin and dapagliflozin
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Safety and tolerability of dapagliflozin
[Time Frame: Screening through completion of the study]
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Secondary ID(s)
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D1690C00001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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