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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-03049423; Drug: PF-03049423; Drug: PF-03049423; Drug: PF-03049423; Drug: PF-03049423; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PF-03049423; Cohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers	Drug: PF-03049423; PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers; Drug: PF-03049423; PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers; Drug: PF-03049423; 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; Drug: PF-03049423; 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; Drug: PF-03049423; 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
PLACEBO_COMPARATOR: Drug; Placebo in oral solution, given once daily for 14 days	Drug: Placebo; Placebo in oral solution, given once daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Blood pressure	Days 1 to 14

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (ESTIMATE): July 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 9, 2011
• Last Update Submitted That Met QC Criteria: August 8, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: phase 1; healthy young adult volunteers; healthy elderly adult volunteers
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; 3-(4-(2-hydroxyethyl)piperazin-1-yl)-7-(6-methoxypyridin-3-yl)-1-(2-propoxyethyl)pyrido(3,4-b)pyrazin-2(1H)-one
• Other Study ID Numbers: A9541002