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

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

Treatment A

Treatment B

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment A - PF-04764793

Treatment B - PF-04764793

Arm Description

PF-04764793 using inhaler A

PF-04764793 using inhaler B

Outcomes

Primary Outcome Measures

Plasma pharmacokinetic parameters: AUClast and Cmax

Secondary Outcome Measures

Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life.

Full Information

NCT ID

NCT00977015

First Posted

August 3, 2009

Last Updated

February 9, 2010

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00977015

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A - PF-04764793

Arm Type

Experimental

Arm Description

PF-04764793 using inhaler A

Arm Title

Treatment B - PF-04764793

Arm Type

Active Comparator

Arm Description

PF-04764793 using inhaler B

Intervention Type

Drug

Intervention Name(s)

Treatment A

Intervention Description

Inhaled, 750/150, single dose

Intervention Type

Drug

Intervention Name(s)

Treatment B

Intervention Description

Inhaled, 750/150, single dose

Primary Outcome Measure Information:

Title

Plasma pharmacokinetic parameters: AUClast and Cmax

Time Frame

Secondary Outcome Measure Information:

Title

Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life.

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

188770

Country

Singapore

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1691002&StudyName=Study%20To%20Estimate%20The%20Time%20Course%20Of%20PF-04764793%20In%20The%20Blood%20Following%20Dosing%20By%20Oral%20Inhalation%20From%20Dry%20Powder%20Inhalers

Description

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

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