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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00809289
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
7
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval in Healthy Volunteers
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: One

Drug: esreboxetine
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.
Placebo Comparator: Two

Drug: placebo
Once daily administration of placebo for 9 days. Placebo will be administered double blind
Active Comparator: Three

Administration of a single oral dse of 400mg moxifloxacin

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

Outcome Measures

Primary Outcome Measures

  1. To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers [Up to 24 hours]

Secondary Outcome Measures

  1. To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval [Up to 24 hours]

  2. To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers [Up to 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Bruxelles Belgium 1070

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00809289
Other Study ID Numbers:
  • A6061065
First Posted:
Dec 17, 2008
Last Update Posted:
Apr 7, 2011
Last Verified:
Apr 1, 2011
Keywords provided by , ,
Thorough QT/QTc study
Additional relevant MeSH terms:
Fibromyalgia
Moxifloxacin

Study Results

No Results Posted as of Apr 7, 2011