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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00809289
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : April 7, 2011
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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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: esreboxetine Drug: placebo Drug: moxifloxacin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : December 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: One 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.
Placebo Comparator: Two Drug: placebo
Once daily administration of placebo for 9 days. Placebo will be administered double blind
Active Comparator: Three
Administration of a single oral dse of 400mg moxifloxacin
Drug: moxifloxacin
Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers [ Time Frame: Up to 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00809289

Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00809289     History of Changes
Other Study ID Numbers: A6061065
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: April 2011

Keywords provided by Pfizer:
Thorough QT/QTc study

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