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

Phase 1

Completed

• Conditions: Pulmonary Disease; Lung Disease; Moxifloxacin
• Interventions: Drug: moxifloxacin; Drug: placebo; Drug: PF-00610355

• Registration Number: NCT01107054
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Study Start: 2010-06
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-12
• Last Update Posted: 2011-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
moxifloxacin 400 mg	moxifloxacin	A single oral dose of moxifloxacin 400 mg on Day 4.
placebo	placebo	A single oral dose of non-matched placebo on Day 4.
PF-00610355 450 µg	PF-00610355	An orally inhaled dose of PF-00610355 450 µg
PF-00610355 1200 µg	PF-00610355	An orally inhaled dose of PF-00610355 1200 µg

Primary Outcome Measures

Name	Time	Method
To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers	24 hours

Secondary Outcome Measures

Name	Time	Method
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers	24 hours
To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval	24 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium