A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.

Official Title
-----------------
A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: PF-04171327
* Drug: Prednisolone
* Drug: Placebo
* Drug: Placebo Solution
* Drug: PF-04171327 Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males between 18 and 55 years, inclusive. Healthy females between 18 and 44 years, inclusive. Exclusion Criteria: Evidence or history of clinically significant disease; Post-menopausal women; History of intolerance or significant adverse effects with glucocorticoids. therapy.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04173127<br> | Drug: PF-04171327<br>* PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days.<br>|
| Active Comparator: Prednisolone<br> | Drug: Prednisolone<br>* Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Tablets similar in appearance to prednisolone will be administered once daily for 14 days.<br>|
| Sham Comparator: Solution Placebo<br> | Drug: Placebo Solution<br>* Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days.<br>|
| Experimental: PF-04171327 Tablet<br> | Drug: PF-04171327 Tablet<br>* A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of multiple doses of PF-04171327 |  | 14 days | 
| Determination of pharmacokinetic parameters of PF-04171327 after multiple doses |  | 14 days | 
| Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers |  | 14 days | 
| Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacodynamic effects of prednisolone |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety Tolerability Pharmacokinetics/pharmacodynamics