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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Fibromyalgia

Treatments: Drug: moxifloxacin; Drug: esreboxetine; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00809289

A6061065

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 3 patient groups, including a placebo group

One

Experimental group

Treatment:

Drug: esreboxetine

Two

Placebo Comparator group

Treatment:

Drug: placebo

Three

Active Comparator group

Description:

Administration of a single oral dse of 400mg moxifloxacin

Treatment:

Drug: moxifloxacin