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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
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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Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers
A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval in Healthy Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Fibromyalgia
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00809289
A6061065
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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