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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: December 16, 2008
Last updated: April 6, 2011
Last verified: April 2011

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 Intervention Phase
Drug: esreboxetine
Drug: placebo
Drug: moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers [ Time Frame: Up to 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers [ Time Frame: Up to 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00809289

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00809289     History of Changes
Other Study ID Numbers: A6061065
Study First Received: December 16, 2008
Last Updated: April 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Thorough QT/QTc study

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Nervous System Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 16, 2014