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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161069
First Posted: July 13, 2010
Last Update Posted: August 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Healthy Drug: PF-03049423 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety laboratory assessments, vital signs (including supine and standing blood pressure), physical examination, 12-lead ECGs and adverse events. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Day 14 ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Days 1 to 14 ]

Enrollment: 48
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161069


Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01161069     History of Changes
Other Study ID Numbers: A9541002
First Submitted: May 7, 2010
First Posted: July 13, 2010
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by Pfizer:
phase 1
healthy young adult volunteers
healthy elderly adult volunteers

Additional relevant MeSH terms:
3-(4-(2-hydroxyethyl)piperazin-1-yl)-7-(6-methoxypyridin-3-yl)-1-(2-propoxyethyl)pyrido(3,4-b)pyrazin-2(1H)-one
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action