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

April 19, 2010
January 12, 2011
June 2010
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01107054 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Pulmonary Disease
  • Lung Disease
  • Moxifloxacin
  • Drug: PF-00610355
    An orally inhaled dose of PF-00610355 450 µg on days 1 to 4
  • Drug: PF-00610355
    An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4
  • Drug: moxifloxacin
    A single oral dose of moxifloxacin 400 mg on Day 4.
  • Drug: placebo
    A single oral dose of non-matched placebo on Day 4.
  • Experimental: PF-00610355 450 µg
    An orally inhaled dose of PF-00610355 450 µg
    Intervention: Drug: PF-00610355
  • Experimental: PF-00610355 1200 µg
    An orally inhaled dose of PF-00610355 1200 µg
    Intervention: Drug: PF-00610355
  • Active Comparator: moxifloxacin 400 mg
    A single oral dose of moxifloxacin 400 mg on Day 4.
    Intervention: Drug: moxifloxacin
  • Placebo Comparator: placebo
    A single oral dose of non-matched placebo on Day 4.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01107054
A7881014
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP