NCT00977015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2009

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 11, 2010

Status Verified

February 1, 2010

Enrollment Period

2 months

First QC Date

August 3, 2009

Last Update Submit

February 9, 2010

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Plasma pharmacokinetic parameters: AUClast and Cmax

    48

Secondary Outcomes (1)

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

    48

Study Arms (2)

Treatment A - PF-04764793

EXPERIMENTAL

PF-04764793 using inhaler A

Drug: Treatment A

Treatment B - PF-04764793

ACTIVE COMPARATOR

PF-04764793 using inhaler B

Drug: Treatment B

Interventions

Treatment ADRUG

Inhaled, 750/150, single dose

Treatment A - PF-04764793
Treatment BDRUG

Inhaled, 750/150, single dose

Treatment B - PF-04764793

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 3, 2009

First Posted

September 15, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 11, 2010

Record last verified: 2010-02

Locations

SG(1)