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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.

NCT ID: NCT01415102

Last Updated: 2011-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Phase 1 Single Dose Safety Toleration Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Subjects will be assigned to receive either PF-05212372 or placebo in each period

Group Type EXPERIMENTAL

PF-05212372

Intervention Type DRUG

Inhaled. Dose Level 1: 50 ug

PF-05212372

Intervention Type DRUG

Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose

PF-05212372

Intervention Type DRUG

Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose

PF-05212372

Intervention Type DRUG

Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose

Placebo

Intervention Type DRUG

Inhaled

Cohort 2

Subjects will be assigned to receive either PF-05212372 or placebo in each period

Group Type EXPERIMENTAL

PF-05212372

Intervention Type DRUG

Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose

PF-05212372

Intervention Type DRUG

Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose

PF-05212372

Intervention Type DRUG

Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose

Placebo

Intervention Type DRUG

Inhaled

Interventions

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PF-05212372

Inhaled. Dose Level 1: 50 ug

Intervention Type DRUG

PF-05212372

Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose

Intervention Type DRUG

PF-05212372

Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose

Intervention Type DRUG

PF-05212372

Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose

Intervention Type DRUG

Placebo

Inhaled

Intervention Type DRUG

PF-05212372

Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose

Intervention Type DRUG

PF-05212372

Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose

Intervention Type DRUG

PF-05212372

Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose

Intervention Type DRUG

Placebo

Inhaled

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2031001&StudyName=A%20First%20In%20Human%20Study%20In%20Healthy%20People%20To%20Evaluate%20Safety%2C%20Toleration%20And%20Time%20Course%20Of%20Plasma%20Concentration%20Of%20Single%20Inhaled%20

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2031001

Identifier Type: -

Identifier Source: org_study_id

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