Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00908271
First received: May 22, 2009
Last updated: June 6, 2014
Last verified: June 2014
  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:


Further study details as provided by AstraZeneca:

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
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: NCT00908271

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

Additional Information:
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: June 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014