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.

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01415102

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Phase 1 Single Dose Safety Toleration Pharmacokinetics	Drug: PF-05212372 Drug: PF-05212372 Drug: PF-05212372 Drug: PF-05212372 Drug: Placebo Drug: PF-05212372 Drug: PF-05212372 Drug: PF-05212372 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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
Experimental: Cohort 2 Subjects will be assigned to receive either PF-05212372 or placebo in each period	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 Drug: Placebo Inhaled

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

Experimental: Cohort 2

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

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

Drug: Placebo

Inhaled

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bruxelles		Belgium	B-1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01415102

Other Study ID Numbers:

B2031001

First Posted:

Aug 11, 2011

Last Update Posted:

Aug 15, 2011

Last Verified:

Aug 1, 2011

Study Results

No Results Posted as of Aug 15, 2011