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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-03049423; Drug: Placebo

• Registration Number: NCT01161069
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-13
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-03049423	PF-03049423	Cohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers
Drug	Placebo	Placebo in oral solution, given once daily for 14 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Blood pressure	Days 1 to 14

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium