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Completed

NCT Number: NCT01181700

A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers

The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.

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Key information

Conditions

Pharmacokinetics

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and/or female subjects between the ages of 21 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Pregnant or nursing females.
  • A positive urine drug screen.

Treatment and study plan

Treatment A

Drug

PF-00241939 300 ug using inhaler A

Treatment B

Drug

PF-00241939 300 ug using inhaler A

Treatment C

Drug

PF-00241939 300 ug using inhaler A

Treatment D

Drug

PF-00241939 300 ug using inhaler B

Treatment E

Drug

PF-00241939 300 ug using inhaler B

Treatment F

Drug

PF-00241939 300 ug using inhaler B

Treatment G

Drug

PF-00241939 300 ug using inhaler B

Primary outcomes

  1. Plasma pharmacokinetic parameters: AUClast and Cmax.

    Time frame: 36 hours

Secondary outcomes

  1. Plasma pharmacokinetic parameters: AUC24, AUCinf, Tmax and half-life.

    Time frame: 36 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2010
Registry last updated
Jan 24, 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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