A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.

August 12, 2011 updated by: Pfizer

A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Single Inhaled Doses Of Pf-05212372 In Healthy Subjects

The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • Belgium
      • Bruxelles, Belgium, B-1070
        • 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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

  • 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.
  • Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Subjects will be assigned to receive either PF-05212372 or placebo in each period
Drug: PF-05212372
Inhaled. Dose Level 1: 50 ug
Drug: PF-05212372
Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: Placebo
Inhaled
Drug: PF-05212372
Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Experimental: Cohort 2
Subjects will be assigned to receive either PF-05212372 or placebo in each period
Drug: PF-05212372
Inhaled. Dose Level 1: 50 ug
Drug: PF-05212372
Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: Placebo
Inhaled
Drug: PF-05212372
Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 14 days
14 days
Plasma pharmacokinetics
Time Frame: up to 72 hours post dose
up to 72 hours post dose
Urine pharmacokinetics
Time Frame: up to 24 hours post dose
up to 24 hours post dose
Urine Pharmacodynamics
Time Frame: up to 24 hours post dose
up to 24 hours post dose

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

September 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 29, 2010

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

August 15, 2011

Last Update Submitted That Met QC Criteria

August 12, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • B2031001

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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