Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers

Study Overview
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Brief Summary
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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-04308515 in healthy volunteers for 14 days as well as one oral dose of a tablet formulation administered for 1 day.

Official Title
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A Phase 1, Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04308515 (Part 1), And A Single Dose Pharmacokinetic Assessment Of A PF-04308515 Tablet Formulation (Part 2), In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04308515
* Drug: Placebo
* Drug: PF-04308515 Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males between 18 and 55 years, inclusive Healthy females between 18 and 44 years, inclusive Females are required to be surgically sterile Exclusion Criteria: Evidence or history of clinically significant disease Post-menopausal women History of intolerance or significant adverse effects with glucocorticoid therapy

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Part 1) PF-04308515<br> | Drug: PF-04308515<br>* PF-04308515 will be provided as an oral solution administered at doses of 3, 10, 30 and 100 mg. If an optional cohort is needed the dose would not exceed the established toxicokinetic exposure limits. Solution will be administered orally once daily for 14 days.<br>|
| Placebo Comparator: (Part 1) Solution Placebo<br> | Drug: Placebo<br>* Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.<br>|
| Experimental: (Part 2) PF-04308515 Tablet<br> | Drug: PF-04308515 Tablet<br>* Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of multiple doses of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs). |  | 14 days | 
| Characterization of pharmacokinetic parameters of PF-04308515 after multiples doses which will include: Cmax, Tmax, AUC, CL/F, Vz/F, t1/2. Urinary excretion including AE% and CLr will be assessed at steady state. |  | 14 days | 
| Change from baseline will be utilized to assess PF-04308515's pharmacodynamic effect on biochemical and metabolic biomarkers after 14 days of dosing. |  | 14 days | 
| For the tablet pharmacokinetics:Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, t1/2 will be calculated from the PF-04308515 plasma concentration versus time data. |  | 1 day | 
| Safety and tolerability of 1 oral dose of a tablet formulation of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs). |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, Rheumatoid Arthritis, healthy volunteers