Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00809289

Purpose

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
Fibromyalgia	Drug: esreboxetine Drug: placebo Drug: moxifloxacin	Phase I

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study
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

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 assses 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 healhy volunteers [ Time Frame: Up to 24 hours ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
One: Experimental	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 diuble-blind
Two: Placebo Comparator	Drug: placebo Once daily administration of placebo for 9 days. Placebo will be administered double blind
Three: Active Comparator Administration of a single oral dse of 400mg moxifloxacin	Drug: moxifloxacin Once daily adminsitration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Evidence or history of clinically signficant 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 ClinicalTrials.gov identifier: NCT00809289

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Belgium
Pfizer Investigational Site	Recruiting
Bruxelles, Belgium, 1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6061065, A6061065
Study First Received:	December 16, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809289
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Thorough QT/QTc study

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Moxifloxacin
Myofascial Pain Syndromes

Fibromyalgia
Pain
Healthy
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009