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Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers (TQT)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
esreboxetine
placebo
moxifloxacin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibromyalgia focused on measuring Thorough QT/QTc study

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male and female subjects aged 18 to 55 years
  • Body mass Index of approximately 18 to 30kg/m2
  • Informed consent document signed by the subject or a legally acceptable representative
  • Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures

Exclusion Criteria:

  • Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
  • Conditions possibly affecting drug absorption
  • 12-lead ECg demonstrating QTc > 450ms or any other clinically significant abnormalities at screen
  • Positive urine drug screen
  • Hypersensitivity to moxifloxacin
  • Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

One

Two

Three

Arm Description

Administration of a single oral dse of 400mg moxifloxacin

Outcomes

Primary Outcome Measures

To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers

Secondary Outcome Measures

To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers

Full Information

First Posted
December 16, 2008
Last Updated
April 6, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00809289
Brief Title
Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers
Acronym
TQT
Official Title
A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Thorough QT/QTc study

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One
Arm Type
Experimental
Arm Title
Two
Arm Type
Placebo Comparator
Arm Title
Three
Arm Type
Active Comparator
Arm Description
Administration of a single oral dse of 400mg moxifloxacin
Intervention Type
Drug
Intervention Name(s)
esreboxetine
Intervention Description
Once daily administration of 4mg esreboxetine for 3 days, followed by 8mg esreboxetine for 3 days, followed by 10mg esreboxetine for 3 days. Drug will be administered double-blind.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Once daily administration of placebo for 9 days. Placebo will be administered double blind
Intervention Type
Drug
Intervention Name(s)
moxifloxacin
Intervention Description
Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9
Primary Outcome Measure Information:
Title
To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval
Time Frame
Up to 24 hours
Title
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male and female subjects aged 18 to 55 years Body mass Index of approximately 18 to 30kg/m2 Informed consent document signed by the subject or a legally acceptable representative Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures Exclusion Criteria: Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening Conditions possibly affecting drug absorption 12-lead ECg demonstrating QTc > 450ms or any other clinically significant abnormalities at screen Positive urine drug screen Hypersensitivity to moxifloxacin Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061065&StudyName=Phase%201%20thorough%20QT%20%28TQT%29%20study%20in%20young%20healthy%20volunteers
Description
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Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers

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