NCT01043276

Brief Summary

The purpose of this study if to investiagte the time course of PF-00258210 plasma concentration in the presence or absence of PF-00610335 administered via 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
20

participants targeted

Target at P25-P50 for phase_1 asthma

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_1 asthma

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

December 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

Enrollment Period

3 months

First QC Date

December 7, 2009

Last Update Submit

April 26, 2010

Conditions

Asthma

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • plasma pharmacokinetics AUClast and Cmax

    Day 1

Secondary Outcomes (1)

  • plasma pharmacokinetics, AUCinf and Tmax

    Day 1

Study Arms (5)

Treatment A

EXPERIMENTAL
Drug: Treatment A

Treatment B

EXPERIMENTAL
Drug: Treatment B

Treatment C

EXPERIMENTAL
Drug: Treatment C

Treatment D

EXPERIMENTAL
Drug: Treatment D

Treatment E

EXPERIMENTAL
Drug: Treatment E

Interventions

Treatment ADRUG

PF-00258210 220 µg using inhaler A

Treatment A
Treatment BDRUG

PF-00258210 220 µg using inhaler A and 450 µg PF-00610335 using inhaler A

Treatment B
Treatment CDRUG

PF-00258210 440 µg and 450 µg PF-00610335 using inhaler A

Treatment C
Treatment DDRUG

PF-00258210 350 µg and 450 µg PF-00610335 using inhaler A

Treatment D
Treatment EDRUG

PF-00258210 220 µg using inhaler B

Treatment E

Eligibility Criteria

Age18 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, inclusive
  • 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
  • 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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

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

December 7, 2009

First Posted

January 6, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 27, 2010

Record last verified: 2010-04

Locations

SG(1)