Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908271
• Other study ID #: MB102-059
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2009
• Last updated: October 14, 2016
• Start date: July 2009
• Est. completion date: August 2009

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute oral bioavailability		Within the 3 days after study drug administration	No
Secondary	Adverse events (AE)		Within the 3 days after study drug administration	Yes
Secondary	Vital signs		Within the 3 days after study drug administration	Yes
Secondary	Clinical safety labs		Within the 3 days after study drug administration	Yes
Secondary	Electrocardiograms (ECGs)		Within the 3 days after study drug administration	Yes

External Links

•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   MB102-059_redacted _CSR _synopsis