NCT00688493

Brief Summary

The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2007

Typical duration for phase_1 healthy

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

Study Start

First participant enrolled

July 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

First QC Date

May 30, 2008

Last Update Submit

March 20, 2012

Conditions

Healthy

Keywords

QTHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Electronic measures of heart beats

    ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication

Secondary Outcomes (2)

  • Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers

    At scheduled times during the 3 day periods following dosing during each of the 4 study periods

  • Safety and tolerability of dapagliflozin

    Screening through completion of the study

Study Arms (4)

20 mg single dose of dapagliflozin

EXPERIMENTAL

20 mg dapagliflozin

Drug: DapagliflozinDrug: MoxifloxacinDrug: Placebo to match moxifloxacin and dapagliflozin

150 mg single dose of dapagliflozin2

EXPERIMENTAL

150 mg dapagliflozin

Drug: DapagliflozinDrug: MoxifloxacinDrug: Placebo to match moxifloxacin and dapagliflozin

400 mg single dose of moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin

Drug: DapagliflozinDrug: MoxifloxacinDrug: Placebo to match moxifloxacin and dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: DapagliflozinDrug: MoxifloxacinDrug: Placebo to match moxifloxacin and dapagliflozin

Interventions

DapagliflozinDRUG

3 x 50 mg tablets, single oral dose

150 mg single dose of dapagliflozin220 mg single dose of dapagliflozin400 mg single dose of moxifloxacinPlacebo
MoxifloxacinDRUG

Overencapsulated 400 mg capsule, single oral dose

Also known as: Avelox™
150 mg single dose of dapagliflozin220 mg single dose of dapagliflozin400 mg single dose of moxifloxacinPlacebo
Placebo to match moxifloxacin and dapagliflozinDRUG

Overencapsulated 400 mg capsule, single oral dose

150 mg single dose of dapagliflozin220 mg single dose of dapagliflozin400 mg single dose of moxifloxacinPlacebo

Eligibility Criteria

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

You may qualify if:

  • Healthy males age 18 to 45 years of age, who are not currently taking any medications
  • Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)

You may not qualify if:

  • No personal or family history of significant heart problems
  • No use of over the counter medications within 7 days of the study
  • No use of prescription medicaiton within 1 month of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Baltimore, Maryland, United States

Location

MeSH Terms

Interventions

dapagliflozinMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Glenn Carlson, MD

    AstraZeneca

    STUDY DIRECTOR

  • Ronald Goldwater, MD

    Parexel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

July 1, 2007

Study Completion

April 1, 2008

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations

US(1)