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

NCT01107054

Last updated date
Study Location
Pfizer Investigational Site
Bruxelles, , 1070, Belgium
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Disease, Lung Disease, Moxifloxacin
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pulmonary Disease, Lung Disease, MoxifloxacinA Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers NCT01107054
  1. Bruxelles,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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