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Completed

NCT Number: NCT01161069

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

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-03049423

Drug

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

Placebo

Drug

Placebo in oral solution, given once daily for 14 days

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. Blood pressure

    Time frame: Days 1 to 14

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 13, 2010
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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