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

Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107054
• Other study ID #: A7881014
• Status: Completed
• Phase: Phase 1
• First received: April 19, 2010
• Last updated: January 12, 2011
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases
• Moxifloxacin
• Pulmonary Disease

Intervention

Drug:
• PF-00610355
An orally inhaled dose of PF-00610355 450 µg on days 1 to 4
• PF-00610355
An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4
• moxifloxacin
A single oral dose of moxifloxacin 400 mg on Day 4.
• placebo
A single oral dose of non-matched placebo on Day 4.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers		24 hours	Yes
Secondary	To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers		24 hours	No
Secondary	To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval		24 hours	Yes

External Links

•   To obtain contact information for a study center near you, click here.