Back to resultsA Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers
Primary Purpose
Pulmonary Disease, Lung Disease, Moxifloxacin
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
PF-00610355
PF-00610355
moxifloxacin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease focused on measuring QTC
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
PF-00610355 450 µg
PF-00610355 1200 µg
moxifloxacin 400 mg
placebo
Arm Description
An orally inhaled dose of PF-00610355 450 µg
An orally inhaled dose of PF-00610355 1200 µg
A single oral dose of moxifloxacin 400 mg on Day 4.
A single oral dose of non-matched placebo on Day 4.
Outcomes
Primary Outcome Measures
To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers
Secondary Outcome Measures
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers
To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01107054
Brief Title
A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Lung Disease, Moxifloxacin
Keywords
QTC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-00610355 450 µg
Arm Type
Experimental
Arm Description
An orally inhaled dose of PF-00610355 450 µg
Arm Title
PF-00610355 1200 µg
Arm Type
Experimental
Arm Description
An orally inhaled dose of PF-00610355 1200 µg
Arm Title
moxifloxacin 400 mg
Arm Type
Active Comparator
Arm Description
A single oral dose of moxifloxacin 400 mg on Day 4.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
A single oral dose of non-matched placebo on Day 4.
Intervention Type
Drug
Intervention Name(s)
PF-00610355
Intervention Description
An orally inhaled dose of PF-00610355 450 µg on days 1 to 4
Intervention Type
Drug
Intervention Name(s)
PF-00610355
Intervention Description
An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4
Intervention Type
Drug
Intervention Name(s)
moxifloxacin
Intervention Description
A single oral dose of moxifloxacin 400 mg on Day 4.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
A single oral dose of non-matched placebo on Day 4.
Primary Outcome Measure Information:
Title
To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers
Time Frame
24 hours
Title
To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7881014&StudyName=A%20Study%20to%20investigate%20the%20effects%20of%20PF00610335%20on%20the%20QT/QTC%20interval%20in%20healthy%20volunteers
Description
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Learn more about this trial
A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers
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