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Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00908271
First received: May 22, 2009
Last updated: February 22, 2011
Last verified: May 2009
History of Changes
  Purpose

The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Dapagliflozin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Absolute oral bioavailability [ Time Frame: Within the 3 days after study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events (AE) [ Time Frame: Within the 3 days after study drug administration ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Within the 3 days after study drug administration ] [ Designated as safety issue: Yes ]
  • Clinical safety labs [ Time Frame: Within the 3 days after study drug administration ] [ Designated as safety issue: Yes ]
  • Electrocardiograms (ECGs) [ Time Frame: Within the 3 days after study drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dapagliflozin
PO and IV
 Drug: Dapagliflozin
Tablet and IV solution, Oral and IV, 10 mg po and 100 µg IV, Single oral dose followed by a single IV dose (IV dose administered at 1h after oral dose), 1 day

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study

Exclusion Criteria:

  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
  • Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility
  • Exposure to significant radiation within 12 months prior to admission to the clinical facility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908271

Locations
United States, Wisconsin
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00908271     History of Changes
Other Study ID Numbers: MB102-059
Study First Received: May 22, 2009
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013