A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to investigate safety and toleration of single oral doses as well as the time course of PF-04418948 concentration in the blood following dosing by oral solution.

Official Title
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A Double-Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Doses Of PF-04418948 In Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04418948
* Drug: PF-04418948
* Drug: PF-04418948
* Drug: PF-04418948
* Drug: PF-04418948
* Drug: PF-04418948
* Drug: PF-04418948


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 18 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs). 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. History of regular alcohol consumption exceeding 21 drinks/week for males.

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

Sexes Eligible for Study
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Male

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04418948 30 mg<br> | Drug: PF-04418948<br>* solution, 30 mg, single<br>|
| Experimental: PF-04418948 100 mg<br> | Drug: PF-04418948<br>* solution, 100 mg, single<br>|
| Experimental: PF-04418948 300 mg<br> | Drug: PF-04418948<br>* solution, 300 mg, single<br>|
| Experimental: PF-04418948 1000 mg<br> | Drug: PF-04418948<br>* solution, 1000 mg, single<br>|
| Experimental: PF-04418948 3000 mg<br> | Drug: PF-04418948<br>* solution, 3000 mg, single<br>|
| Experimental: PF-04418948 4500 mg<br> | Drug: PF-04418948<br>* solution, 4500 mg, single<br>|
| Experimental: PF-04418948 6000 mg<br> | Drug: PF-04418948<br>* solution, 6000 mg, single<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2 |  | 240 hours | 
| Safety: Adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood safety tests, fecal occult blood (FOB), cardiac troponin measurements, urine safety tests (KIM-1 measurements and creatinine). |  | 240 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: Emax (maximum observed increase in TNFα concentration from pre-dose level) TEmax (time to Emax), AUEClast, AUECt (where t will be a defined timepoint) and maximum n-fold increase in concentration from pre-dose level. |  | 48 hours |