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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
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

NCT01107054
Pfizer
Completed
A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers

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[email protected]

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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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01107054
A7881014
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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