Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.

Study Overview
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Brief Summary
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This study is designed to investigate the safety, tolerability, and pharmacokinetics of PF-04447943 after single and multiple-dose administration to healthy young adult and elderly Japanese subjects, respectively.

Official Title
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An Investigator- And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04447943 After Administration Of Single Oral Doses To Healthy Young Adult Japanese Subjects And Multiple Oral Doses To Healthy Elderly Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04447943
* Drug: PF-04447943
* Drug: PF-04447943
* Drug: Placebo
* Drug: PF-04447943
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For young cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 18 and 55 years, inclusive. For elderly cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 65 and 85 years, inclusive. Body Mass Index (BMI) between 17.5 to 30.5 kg/m2, and a total body weight >50 kg (110 lbs). Exclusion Criteria: Pregnant or nursing women; women of childbearing potential. Males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose<br>3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects. | Drug: PF-04447943<br>* 3 mg solution, oral single dose.<br>Drug: PF-04447943<br>* 10 mg solution, oral single dose.<br>Drug: PF-04447943<br>* 25 mg solution, oral single dose.<br>Drug: Placebo<br>* Solution, oral single dose.<br>|
| Experimental: Multiple dose<br>3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects. | Drug: PF-04447943<br>* 25 mg solution, oral twice daily for 7 days.<br>Drug: Placebo<br>* Solution, oral twice daily for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs (spontaneous and solicited). Change from baseline in vital signs. |  | Day 0 to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm) | 
| ECG and clinical safety laboratory endpoints, including a complete blood count, a full chemistry panel (including electrolytes and hepatic transaminases) and urinalysis. |  | Screening visit to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm) | 
| Pharmacokinetic (single): AUClast, Cmax, Tmax |  | Day 1 to day 5 | 
| Pharmacokinetic(multiple): AUCt, Cmax and Tmax on Days 1 and 7, and Ctrough on Days 2, 3, 4 and 7. |  | Day 1 to day 11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Pharmacokinetics, Healthy Young Adult, Japanese, Healthy Elderly, Alzheimer disease