Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.

Official Title
-----------------
A Phase 1, Dose Expansion Of A Within-cohort, Randomized, Double-blind, Third-party Open, Placebo-controlled, Single-and Multiple-dose Escalation Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of Pf-06473871 In Normal Healthy Adults

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: 80 mg PF-06473871
* Drug: 160 mg PF-06473871
* Drug: 320 mg PF-06473871
* Drug: 480 mg PF-06473871


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or females between the ages of 18 and 55 years inclusive Exclusion Criteria: Currently pregnant

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: 80 mg PF-06473871<br>* 80 mg of PF-06473871 or placebo<br>|
| Experimental: Cohort 2<br> | Drug: 160 mg PF-06473871<br>* 160 mg of PF-06473871 or placebo<br>|
| Experimental: Cohort 3<br> | Drug: 320 mg PF-06473871<br>* 320 mg of PF-06473871 or placebo<br>|
| Experimental: Cohort 4<br> | Drug: 480 mg PF-06473871<br>* 480 mg of PF-06473871 or placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse events | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks | 
| ECGs | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks | 
| Blood pressure | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks | 
| pulse rate | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks | 
| Injection siter reaction | The number and percentage of subjects that experienced injection site reactions will be analyzed. | 6 weeks | 
| number of subjects with adverse events | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks | 
| severity of adverse events | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 6 weeks | 
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | 6 weeks | 
| Maximum Observed Plasma Concentration (Cmax) |  | 6 weeks |