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Completed

NCT Number: NCT01107054

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

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

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Key information

Conditions

Pulmonary Disease Lung Disease Lung Diseases Moxifloxacin Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-00610355

Drug

An orally inhaled dose of PF-00610355 450 µg on days 1 to 4

moxifloxacin

Drug

A single oral dose of moxifloxacin 400 mg on Day 4.

Placebo

Drug

A single oral dose of non-matched placebo on Day 4.

Primary outcomes

  1. To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers

    Time frame: 24 hours

Secondary outcomes

  1. To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers

    Time frame: 24 hours

  2. To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 20, 2010
Registry last updated
Jan 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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