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This Study Is 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

Treatment C

Treatment D

Treatment E

Treatment F

Treatment G

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 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Arm Label

Treatment A PF-04764793

Treatment B PF-04764793

Treatment C PF-04764793

Treatment D PF-04764793

Treatment E PF-04764793

Treatment F PF-04764793

Treatment G PF-04764793

Arm Description

PF-04764793 using inhaler A

PF-04764793 using inhaler B

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT01272375

First Posted

January 6, 2011

Last Updated

November 29, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01272375

Brief Title

This Study Is 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

November 2018

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (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

48 (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

Experimental

Arm Description

PF-04764793 using inhaler A

Arm Title

Treatment C PF-04764793

Arm Type

Experimental

Arm Description

PF-04764793 using inhaler A

Arm Title

Treatment D PF-04764793

Arm Type

Experimental

Arm Description

PF-04764793 using inhaler A

Arm Title

Treatment E PF-04764793

Arm Type

Experimental

Arm Description

PF-04764793 using inhaler B

Arm Title

Treatment F PF-04764793

Arm Type

Experimental

Arm Description

PF-04764793 using inhaler B

Arm Title

Treatment G PF-04764793

Arm Type

Experimental

Arm Description

PF-04764793 using inhaler B

Intervention Type

Drug

Intervention Name(s)

Treatment A

Intervention Description

PF-04764793 250/50 using inhaler A

Intervention Type

Drug

Intervention Name(s)

Treatment B

Intervention Description

PF-04764793 250/50 using inhaler A

Intervention Type

Drug

Intervention Name(s)

Treatment C

Intervention Description

PF-04764793 250/50 using inhaler A

Intervention Type

Drug

Intervention Name(s)

Treatment D

Intervention Description

PF-04764793 250/50 using inhaler A

Intervention Type

Drug

Intervention Name(s)

Treatment E

Intervention Description

PF-04764793 250/50 using inhaler B

Intervention Type

Drug

Intervention Name(s)

Treatment F

Intervention Description

PF-04764793 250/50 using inhaler B

Intervention Type

Drug

Intervention Name(s)

Treatment G

Intervention Description

PF-04764793 250/50 using inhaler B

Primary Outcome Measure Information:

Title

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

Title

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

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

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

Title

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

Time Frame

48 hours

Title

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

Time Frame

48 hours

Title

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

Time Frame

48 hours

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=B1691011&StudyName=An%20Open%20Study%20To%20Estimate%20The%20Plasma%20Pharmacokinetics%20Of%20PF-04764793%20Administered%20Via%20Oral%20Inhalation%20Using%20Dry%20Powder%20Inhalers

Description

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

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