A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.

Study Overview
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Brief Summary
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This study is designed to observe the safety and blood concentrations of PF-04995274 during and following the administration of multiple doses of PF-04995274 for a duration of 14 days, in healthy adult and healthy elderly.

Detailed Description
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To examine the safety and pharmacokinetics of PF-04995274 in healthy adult and healthy elderly subjects after multiple doses.

Official Title
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An Investigator And Subject-Blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: 0.1 mg PF-04995274
* Drug: 1 mg PF-04995274
* Drug: 10 mg PF-04995274
* Drug: 15 mg PF-04995274
* Drug: 1.0 mg PF-04995274
* Drug: 15 mg PF-04995274


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential 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 heart rate measurement, 12 lead ECG and clinical laboratory tests.) For Healthy Elderly volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 65 and 85 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the Alzheimer's Disease (AD) population, no more than 30% of subjects enrolled in any cohort may be less than 70 years of age. 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).

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing Healthy Adult<br>Ascending Doses in Healthy Adult Volunteers | Drug: 0.1 mg PF-04995274<br>* 0.1 mg PF-04995274, qd, for 14 days or placebo<br>Drug: 1 mg PF-04995274<br>* 1 mg PF-04995274, qd, for 14 days or placebo<br>Drug: 10 mg PF-04995274<br>* 10 mg PF-04995274, qd, for 14 days or placebo<br>Drug: 15 mg PF-04995274<br>* 15 mg PF-04995274, qd, for 14 days or placebo<br>|
| Experimental: Dosing Healthy Elderly<br>Dosing in Healthy Elderly volunteers | Drug: 1.0 mg PF-04995274<br>* 1.0 mg PF-04995274, qd, for 14 days or placebo<br>Drug: 15 mg PF-04995274<br>* 15 mg PF-04995274, qd, for 14 days or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoints (Adverse events, Change from baseline in vital signs, Change from baseline in triplicate ECGs, Clinical safety laboratory, Clinical examinations, Digit Symbol Substitution Test (DSST)) |  | Day 0 to Day 28 | 
| Pharmacokinetic endpoints Plasma concentration of PF 04995274 over time (eg, AUC, Cmax, Tmax, t1/2), Plasma concentration of PF 05082547 over time (eg, AUC, Cmax, Tmax, t1/2). |  | Day 0 to Day 28 | 
| Pharmacodynamic endpoint Aldosterone concentration in healthy adult subjects. |  | Day 0 to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcomes |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple dose, healthy volunteer, healthy elderly volunteer, safety, pharmacokinetic