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

NCT00809289 | Completed Phase 1

• 1 other identifier: A6061065
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Thorough QT/QTc study

Outcome Measures

Primary Outcomes (1)

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

  Up to 24 hours

Secondary Outcomes (2)

• 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

Study Arms (3)

One

EXPERIMENTAL

Drug: esreboxetine

Two

PLACEBO COMPARATOR

Drug: placebo

Three

ACTIVE COMPARATOR

Administration of a single oral dse of 400mg moxifloxacin

Drug: moxifloxacin

Interventions

esreboxetine DRUG

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.

One

placebo DRUG

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

Two

moxifloxacin DRUG

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

Three

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Fibromyalgia

Interventions

esreboxetine; Moxifloxacin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 7, 2011

Record last verified: 2011-04

Locations

BE (1)