Effects of Single Oral Dose Dapagliflozin QT 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”

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

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 20 mg single dose of dapagliflozin
  • 20 mg dapagliflozin
• Experimental: 150 mg single dose of dapagliflozin2
  • 150 mg dapagliflozin
• Active Comparator: 400 mg single dose of moxifloxacin
  • Moxifloxacin
• Placebo Comparator: Placebo
  • Placebo

Primary 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
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: No
• Safety and tolerability of dapagliflozin
  • Time Frame: Screening through completion of the study
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Glenn Carlson, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00688493

Study ID Number: D1690C00001

ClinicalTrials.gov Identifier: NCT00688493

Health Authority: United States: Food and Drug Administration