To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity

Study Overview
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Brief Summary
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The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.

Official Title
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An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-05186462, PF-05089771, PF-05241328 And PF-05150122 In Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-05186462
* Drug: PF-05186462
* Drug: PF-05089771
* Drug: PF-05089771
* Drug: PF-05150122
* Drug: PF-05150122
* Drug: PF-05241328
* Drug: PF-05241328


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male subjects between the ages of 18 and 50 years inclusive. (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) Body Mass Index (BMI) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. Exclusion Criteria: Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing) History of febrile illness within 5 days prior to the first dose a positive urine drug screen

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous: PF-05186462<br> | Drug: PF-05186462<br>* single intravenous infusion of 100 microgram<br>|
| Active Comparator: Oral: PF-05186462<br> | Drug: PF-05186462<br>* single oral administration of 100 microgram<br>|
| Active Comparator: Intravenous: PF-05089771<br> | Drug: PF-05089771<br>* single intravenous infusion of 100 microgram of PF-05089771<br>|
| Active Comparator: Oral: PF-05089771<br> | Drug: PF-05089771<br>* single oral administration of 100 microgram PF-05089771<br>|
| Active Comparator: Intravenous: PF-05150122<br> | Drug: PF-05150122<br>* single intravenous administration of 100 microgram PF-05150122<br>|
| Active Comparator: Oral: PF-05150122<br> | Drug: PF-05150122<br>* single oral administration of 100 microgram PF-05150122<br>|
| Active Comparator: Intravenous: PF-05241328<br> | Drug: PF-05241328<br>* single intravenous infusion of 100 microgram PF-05241328<br>|
| Active Comparator: Oral: PF-05241328<br> | Drug: PF-05241328<br>* single oral administration 100 microgram PF-05241328<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry) |  | up to 3 days post dose | 
| pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve |  | up to 3 days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry) |  | up to 3 days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, safety, tolerability, Chronic Pain