Effects of Single Oral Dose Dapagliflozin QT Study

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00688493
First received: May 30, 2008
Last updated: March 20, 2012
Last verified: March 2012
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Safety and tolerability of dapagliflozin [ Time Frame: Screening through completion of the study ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 International
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00688493     History of Changes
Other Study ID Numbers: D1690C00001
Study First Received: May 30, 2008
Last Updated: March 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
QT
Healthy volunteers

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014