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Trial record 1 of 1 for:    NCT01107054
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A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01107054
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : January 13, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 19, 2010
First Posted Date  ICMJE April 20, 2010
Last Update Posted Date January 13, 2011
Study Start Date  ICMJE June 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
  • To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers [ Time Frame: 24 hours ]
  • To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Disease
  • Lung Disease
  • Moxifloxacin
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2010)
48
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2010)
42
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01107054
Other Study ID Numbers  ICMJE A7881014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2011

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