Study of the Absolute Oral Bioavailability of Dapaglifloz... | NCT00908271

Studies
Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

NCT00908271

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 17, 2016Estimated

Enrollment

7Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

Dapagliflozin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

May 22, 2009

First Submission Date that Met QC Criteria

May 22, 2009

First Posted Date

May 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2016

Last Update Posted Date

Oct 17, 2016Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dapagliflozin	Other	PO and IV	Drug: Dapagliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absolute oral bioavailability		Within the 3 days after study drug administration

Secondary Outcomes

Measure	Description	Time Frame
Adverse events (AE)		Within the 3 days after study drug administration
Vital signs		Within the 3 days after study drug administration
Clinical safety labs

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Covance Clinical Research Unit, Inc.		Madison	Wisconsin	53704	United States

Label	URL
MB102-059\_redacted \_CSR \_synopsis	View source

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C529054	dapagliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided