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

Pfizer40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Fibromyalgia

Interventions

esreboxetineDRUG

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.

placeboDRUG

Once daily administration of placebo for 9 days. Placebo will be administered double blind

moxifloxacinDRUG

Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers

Time frame: Up to 24 hours

Secondary Outcomes

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

To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers

Time frame: Up to 24 hours

Data from ClinicalTrials.gov

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