Multiple Dose Healthy Volunteer Study of PF-03715455. (MD-MULTI DOSE)

January 11, 2011 updated by: Pfizer

A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03715455 In Healthy Subjects

Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy volunteer PK study

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 188770
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Standard healthy volunteer criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Active Comparator: PF-03715455 1.6mg BID
Drug: PF-03715455
PF-03715455 1.6 mg BID
Drug: PF-03715455
PF-03715455 4mg BID
Drug: PF-03715455
PF-03715455 10 mg BID
Active Comparator: PF-03715455 4 mg BID
Drug: PF-03715455
PF-03715455 1.6 mg BID
Drug: PF-03715455
PF-03715455 4mg BID
Drug: PF-03715455
PF-03715455 10 mg BID
Active Comparator: PF-03715455 10 mg BID
Drug: PF-03715455
PF-03715455 1.6 mg BID
Drug: PF-03715455
PF-03715455 4mg BID
Drug: PF-03715455
PF-03715455 10 mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax).
Time Frame: 17 days
17 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
Time Frame: 28 Days
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

August 11, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2011

Last Update Submitted That Met QC Criteria

January 11, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • A9111002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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