A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers

Study Overview
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Brief Summary
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The purpose this study is to evaluate the safety and toleration of PF-03049423 following multiple dose administration as an oral solution to healthy young adult volunteers and healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423 after multiple dose administration to healthy young adult volunteers and healthy elderly volunteers. The study will also explore the relationship between blood pressure (supine and standing) and PF-03049423 concentration.

Detailed Description
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The purpose of the investigation is to evaluate the safety and tolerability of an investigational new drug, PF-03049423, when dosed for two weeks in both healthy younger and healthy older subjects.

Official Title
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A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Parallel Group, Multiple Dose Escalation Study To Evaluate The Safety, Toleration, Pharmacokinetics Of PF-03049423 In Healthy Young Adult Volunteers And Healthy Elderly Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-03049423
* Drug: PF-03049423
* Drug: PF-03049423
* Drug: PF-03049423
* Drug: PF-03049423
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy persons, male or female. For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive. For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive. Body Mass Index (BMI) of 18 to 35; and a total body weight >50 kg (110 lbs) Exclusion Criteria: Subjects with clinically significant medical conditions. Women of non-child bearing potential. Subjects with a known medical history of hearing loss/disability or nonarteritic ischemic optic neuropathy. A positive urine drug screen.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: PF-03049423<br>Cohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers | Drug: PF-03049423<br>* PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers<br>Drug: PF-03049423<br>* PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers<br>Drug: PF-03049423<br>* PF-03049423 in oral solution, 6 mg, given once daily for 7 days, then 12 mg given once daily for 7 days; healthy young adult volunteers<br>Drug: PF-03049423<br>* PF-03049423 in oral solution, 3 mg, given once daily for 7 days, then 6 mg given once daily for 7 days; healthy elderly adult volunteers<br>Drug: PF-03049423<br>* PF-03049423 in oral solution, 5 mg, given once daily for 7 days, then 10 mg given once daily for 7 days; healthy elderly adult volunteers<br>|
| Placebo Comparator: Drug<br>Placebo in oral solution, given once daily for 14 days | Drug: Placebo<br>* Placebo in oral solution, given once daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety laboratory assessments, vital signs (including supine and standing blood pressure), physical examination, 12-lead ECGs and adverse events. |  | Days 1 through 14 | 
| PK Parameters:Day 1: Area under concentration time curve from hour 0 to the last dosing interval (AUCtau), maximum observed concentration (Cmax), and time of maximum observed concentration (Tmax), for PF-03049423 in plasma. |  | Day 1 | 
| PK Parameters: Day 14: Cmax at steady state, Tmax, AUCtau at steady state , t½, Cavg at steady state, Cmin at steady state, Cmax at steady state /Cmax sd, AUCtau at steady state/ AUCtau sd, Ae% and CLr. |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Days 1 to 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phase 1, healthy young adult volunteers, healthy elderly adult volunteers