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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PF-03049423

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01161069

A9541002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.