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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval in Healthy Volunteers

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: esreboxetine
* Drug: placebo
* Drug: moxifloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One<br> | Drug: esreboxetine<br>* 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.<br>|
| Placebo Comparator: Two<br> | Drug: placebo<br>* Once daily administration of placebo for 9 days. Placebo will be administered double blind<br>|
| Active Comparator: Three<br>Administration of a single oral dse of 400mg moxifloxacin | Drug: moxifloxacin<br>* Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers |  | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thorough QT/QTc study