A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals

Study Overview
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Brief Summary
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This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.

Detailed Description
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To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.

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-03382792 In Healthy Elderly Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-03382792 0.5mg
* Drug: PF-03382792 1.5 mg
* Drug: PF-03382792 5 mg
* Drug: PF-03382792 15 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer aged 65-80 years old Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 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). Subjects with symptoms or signs of adrenal insufficiency. Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 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: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing<br>Ascending Doses | Drug: PF-03382792 0.5mg<br>* 0.5 mg PF-03382792, qd, for 14 days or placebo<br>Drug: PF-03382792 1.5 mg<br>* 1.5 mg PF-03382792, qd, for 14 days or placebo<br>Drug: PF-03382792 5 mg<br>* 5 mg PF-03382792, qd, for 14 days or placebo<br>Drug: PF-03382792 15 mg<br>* 15 mg PF-03382792, 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 include: AEs, vital signs, triplicate ECGs, |  | Day 0 to Day 28 | 
| Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations |  | Day 0 to Day 28 | 
| Safety Endpoints include: safety laboratory endpoints (including a complete blood count and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive), |  | Day 0 to Day 28 | 
| Pharmacokinetic endpoints include: Plasma concentrations of PF 03382792 and its N dealkylated metabolite, PF 03227077, will be measured and used to determine Cmax, Tmax, AUC on Day 1 and Css,max, Tss,max, AUC, Css,min, Css,avg on Days 7 and 14. |  | Day 0 to Day 28 | 
| Additional pharmacokinetic endpoints: the accumulation ratio (Rac) will be determined from Day 14 and Day 1 AUC. If data permit, t1/2 and urinary excretion parameters (CLR for the parent and Ae and Ae%) will be calculated. |  | Day 0 to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mulitple dose, pharmacokinetics, safety, healthy elderly volunteers