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Effects of Single Oral Dose Dapagliflozin QT Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688493
First Posted: June 3, 2008
Last Update Posted: March 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males

Condition Intervention Phase
Healthy Drug: Dapagliflozin Drug: Moxifloxacin Drug: Placebo to match moxifloxacin and dapagliflozin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome 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 ]

Secondary Outcome 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 and tolerability of dapagliflozin [ Time Frame: Screening through completion of the study ]

Enrollment: 36
Study Start Date: July 2007
Study Completion Date: April 2008
Arms Assigned Interventions
Experimental: 20 mg single dose of dapagliflozin
20 mg dapagliflozin
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
Other Name: Avelox™
Drug: Placebo to match moxifloxacin and dapagliflozin
Overencapsulated 400 mg capsule, single oral dose
Experimental: 150 mg single dose of dapagliflozin2
150 mg dapagliflozin
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
Other Name: Avelox™
Drug: Placebo to match moxifloxacin and dapagliflozin
Overencapsulated 400 mg capsule, single oral dose
Active Comparator: 400 mg single dose of moxifloxacin
Moxifloxacin
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
Other Name: Avelox™
Drug: Placebo to match moxifloxacin and dapagliflozin
Overencapsulated 400 mg capsule, single oral dose
Placebo Comparator: Placebo
Placebo
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
Other Name: Avelox™
Drug: Placebo to match moxifloxacin and dapagliflozin
Overencapsulated 400 mg capsule, single oral dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688493


Locations
United States, Maryland
Research Site
Baltimore, Maryland, United States
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Glenn Carlson, MD AstraZeneca
Principal Investigator: Ronald Goldwater, MD Parexel
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00688493     History of Changes
Other Study ID Numbers: D1690C00001
First Submitted: May 30, 2008
First Posted: June 3, 2008
Last Update Posted: March 21, 2012
Last Verified: March 2012

Keywords provided by AstraZeneca:
QT
Healthy volunteers

Additional relevant MeSH terms:
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors