NCT00862667

Brief Summary

The purpose of this study is to investigate the time course of PF-00241939 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 May 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

February 19, 2009

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

1 month

First QC Date

February 19, 2009

Last Update Submit

June 23, 2009

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Plasma pharmacokinetic parameters: AUClast & Cmax.

    48 hours

Secondary Outcomes (1)

  • Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½.

    48 hours

Study Arms (3)

Treatment A

EXPERIMENTAL

PF-00241939 300ug using Inhaler A

Drug: Treatment A

Treatment B

ACTIVE COMPARATOR

PF-00241939 300ug using Inhaler B

Drug: Treatment B

Treatment C

ACTIVE COMPARATOR

PF-00241939 300ug using Inhaler C

Drug: Treatment C

Interventions

Treatment ADRUG

PF-00241939 300ug using Inhaler A

Treatment A
Treatment BDRUG

PF-00241939 300ug using Inhaler B

Treatment B
Treatment CDRUG

PF-00241939 300ug using Inhaler C

Treatment C

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/m2; 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

February 19, 2009

First Posted

March 17, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 24, 2009

Record last verified: 2009-06

Locations

SG(1)