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A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01107054
First received: April 19, 2010
Last updated: January 12, 2011
Last verified: January 2011
History of Changes
  Purpose

A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.


Condition Intervention Phase
Pulmonary Disease
Lung Disease
Moxifloxacin
 Drug: PF-00610355
Drug: moxifloxacin
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Multiple Dose, Placebo And Active Controlled 4-Way Crossover Study To Investigate The Effects Of Inhaled PF-00610355 On QT/QTC Interval In Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00610355 450 µg
An orally inhaled dose of PF-00610355 450 µg
 Drug: PF-00610355
An orally inhaled dose of PF-00610355 450 µg on days 1 to 4
Experimental: PF-00610355 1200 µg
An orally inhaled dose of PF-00610355 1200 µg
 Drug: PF-00610355
An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4
Active Comparator: moxifloxacin 400 mg
A single oral dose of moxifloxacin 400 mg on Day 4.
 Drug: moxifloxacin
A single oral dose of moxifloxacin 400 mg on Day 4.
Placebo Comparator: placebo
A single oral dose of non-matched placebo on Day 4.
 Drug: placebo
A single oral dose of non-matched placebo on Day 4.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects aged 18 to 55 years
  • 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 or PF00610335
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107054

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01107054     History of Changes
Other Study ID Numbers: A7881014
Study First Received: April 19, 2010
Last Updated: January 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
QTC

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013