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.

Study Overview
=================
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.

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

Conditions
-----------------
Phase 1, Single Dose, Safety, Toleration, Pharmacokinetics

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |