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

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NCT00809289

Last updated on April 3, 2020
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00809289
Pfizer
Completed
Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers
Official Title  ICMJE A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval in Healthy Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: esreboxetine
    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.
  • Drug: placebo
    Once daily administration of placebo for 9 days. Placebo will be administered double blind
  • Drug: moxifloxacin
    Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9
Study Arms  ICMJE
  • Experimental: One
    Intervention: Drug: esreboxetine
  • Placebo Comparator: Two
    Intervention: Drug: placebo
  • Active Comparator: Three
    Administration of a single oral dse of 400mg moxifloxacin
    Intervention: Drug: moxifloxacin
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 16, 2008) 		40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809289
Other Study ID Numbers  ICMJE A6061065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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