Trial record 2 of 2 for:    PF-03049423

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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01161069
First received: May 7, 2010
Last updated: August 8, 2011
Last verified: August 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Days 1 to 14 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01161069     History of Changes
Other Study ID Numbers: A9541002
Study First Received: May 7, 2010
Last Updated: August 8, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on April 17, 2014