A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers

Study Overview
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Brief Summary
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This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days

Official Title
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Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of PF-06412562 In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: 3 mg PF-06412562
* Drug: 10 mg PF-06412562
* Drug: 25 mg PF-06412562
* Drug: PF-06412562 TBD mg
* Drug: PF-06412562 TBD mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 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 30.5 kg/m2; 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). Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: 3 mg PF-06412562<br>* oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days<br>|
| Experimental: Cohort 2<br> | Drug: 10 mg PF-06412562<br>* oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days<br>|
| Experimental: Cohort 3<br> | Drug: 25 mg PF-06412562<br>* oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days<br>|
| Experimental: Optional Cohort 4<br> | Drug: PF-06412562 TBD mg<br>* oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts<br>|
| Experimental: Optional Cohort 5<br> | Drug: PF-06412562 TBD mg<br>* oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS. |  | 0-15 days | 
| Pharmacokinetics: Cmax, Tmax, AUCτ Ctrough, PTR, Rac on Cmax and AUCτ t1/2, CL/F, PTR, |  | 0-15 days | 
| CogState at followup |  | 22-25 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple doses, pharmacokinetics, safety, tolerability, healthy volunteers, steady state, cognitive impairment associated with schizophrenia