NCT00908271

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

May 22, 2009

Last Update Submit

October 14, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Absolute oral bioavailability

    Within the 3 days after study drug administration

Secondary Outcomes (4)

  • Adverse events (AE)

    Within the 3 days after study drug administration

  • Vital signs

    Within the 3 days after study drug administration

  • Clinical safety labs

    Within the 3 days after study drug administration

  • Electrocardiograms (ECGs)

    Within the 3 days after study drug administration

Study Arms (1)

Dapagliflozin

OTHER

PO and IV

Drug: Dapagliflozin

Interventions

DapagliflozinDRUG

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

Dapagliflozin

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 25, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

US(1)