NCT01181700

Brief Summary

The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_1

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 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

3 months

First QC Date

August 11, 2010

Last Update Submit

January 21, 2011

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Plasma pharmacokinetic parameters: AUClast and Cmax.

    36 hours

Secondary Outcomes (1)

  • Plasma pharmacokinetic parameters: AUC24, AUCinf, Tmax and half-life.

    36 hours

Study Arms (7)

Treatment A

EXPERIMENTAL
Drug: Treatment A

Treatment B

EXPERIMENTAL
Drug: Treatment B

Treatment C

EXPERIMENTAL
Drug: Treatment C

Treatment D

ACTIVE COMPARATOR
Drug: Treatment D

Treatment E

ACTIVE COMPARATOR
Drug: Treatment E

Treatment F

ACTIVE COMPARATOR
Drug: Treatment F

Treatment G

ACTIVE COMPARATOR
Drug: Treatment G

Interventions

Treatment ADRUG

PF-00241939 300 ug using inhaler A

Treatment A
Treatment BDRUG

PF-00241939 300 ug using inhaler A

Treatment B
Treatment CDRUG

PF-00241939 300 ug using inhaler A

Treatment C
Treatment DDRUG

PF-00241939 300 ug using inhaler B

Treatment D
Treatment EDRUG

PF-00241939 300 ug using inhaler B

Treatment E
Treatment FDRUG

PF-00241939 300 ug using inhaler B

Treatment F
Treatment GDRUG

PF-00241939 300 ug using inhaler B

Treatment G

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).
  • Pregnant or nursing females.
  • A positive urine drug screen.

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 11, 2010

First Posted

August 13, 2010

Study Start

October 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

SG(1)