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Completed

NCT Number: NCT01272375

This Study Is To Estimate The Time Course Of Pf-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

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Key information

Conditions

Healthy

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/m^2; 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).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
  • Pregnant or nursing females.

Treatment and study plan

Treatment A

Drug

PF-04764793 250/50 using inhaler A

Treatment B

Drug

PF-04764793 250/50 using inhaler A

Treatment C

Drug

PF-04764793 250/50 using inhaler A

Treatment D

Drug

PF-04764793 250/50 using inhaler A

Treatment E

Drug

PF-04764793 250/50 using inhaler B

Treatment F

Drug

PF-04764793 250/50 using inhaler B

Treatment G

Drug

PF-04764793 250/50 using inhaler B

Primary outcomes

  1. Plasma pharmacokinetic parameter: Area under the curve (AUClast)from the time of dosing to the last data point taken for PF-04764793

    Time frame: 48 hours

  2. Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma.

    Time frame: 48 hours

Secondary outcomes

  1. Plasma pharmacokinetic parameter: Area under the curve (AUC0-24) from time of dosing to 24 hours post dose for PF-04764793.

    Time frame: 48 hours

  2. Plasma pharmacokinetic parameter: Area under the curve (AUCinf) from the time of dosing extrapolated to infinity for PF-04764793.

    Time frame: 48 hours

  3. Plasma pharmacokinetic parameter: Time of maximum (Tmax) concentration of PF-04764793 in plasma.

    Time frame: 48 hours

  4. Plasma pharmacokinetic parameter: Terminal half-life of PF-04764793.

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
Dec 3, 2018

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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