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

Fibromyalgia Clinical Trial

— TQT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809289
• Other study ID #: A6061065
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2008
• Last updated: April 6, 2011
• Start date: December 2008
• Est. completion date: July 2009

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fibromyalgia

Intervention

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
Once daily administration of placebo for 9 days. Placebo will be administered double blind
• moxifloxacin
Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers		Up to 24 hours	Yes
Secondary	To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval		Up to 24 hours	Yes
Secondary	To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers		Up to 24 hours	Yes

External Links

•   To obtain contact information for a study center near you, click here.