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OpenTrials
Completed

NCT Number: NCT00688493

Effects of Single Oral Dose Dapagliflozin QT Study

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

3 x 50 mg tablets, single oral dose

moxifloxacin

Drug

Overencapsulated 400 mg capsule, single oral dose

Other names: Avelox™

Placebo to match moxifloxacin and dapagliflozin

Drug

Overencapsulated 400 mg capsule, single oral dose

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Safety and tolerability of dapagliflozin

    Time frame: Screening through completion of the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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