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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 19, 2010

Last Updated Date

January 12, 2011

Start Date ^ICMJE

June 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01107054 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

December 2010

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01107054

Other Study ID Numbers ^ICMJE

A7881014

Has Data Monitoring Committee

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

Information Provided By

Pfizer

Verification Date

January 2011

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

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