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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01161069

Enrollment

Registered

2010-07-13

Start date

2009-08-31

Completion date

2009-12-31

Last updated

2011-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

phase 1, healthy young adult volunteers, healthy elderly adult volunteers

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.

Interventions

DRUGPF-03049423

PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers

DRUGPlacebo

Placebo in oral solution, given once daily for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
Blood pressure	Days 1 to 14

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026