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

Phase 1

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: esreboxetine; Drug: placebo; Drug: moxifloxacin

• Registration Number: NCT00809289
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-06
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
One	esreboxetine	-
Two	placebo	-
Three	moxifloxacin	Administration of a single oral dse of 400mg moxifloxacin

Primary Outcome Measures

Name	Time	Method
To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers	Up to 24 hours

Secondary Outcome Measures

Name	Time	Method
To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval	Up to 24 hours
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers	Up to 24 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium