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

NCT01161069 | Completed Phase 1

• 1 other identifier: A9541002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

phase 1; healthy young adult volunteers; healthy elderly adult volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Blood pressure

  Days 1 to 14

Study Arms (2)

PF-03049423

ACTIVE COMPARATOR

Cohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers

Drug: PF-03049423

Drug

PLACEBO COMPARATOR

Placebo in oral solution, given once daily for 14 days

Drug: Placebo

Interventions

PF-03049423 DRUG

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

PF-03049423

Placebo DRUG

Placebo in oral solution, given once daily for 14 days

Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

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

MeSH Terms

Interventions

3-(4-(2-hydroxyethyl)piperazin-1-yl)-7-(6-methoxypyridin-3-yl)-1-(2-propoxyethyl)pyrido(3,4-b)pyrazin-2(1H)-one

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: July 13, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 9, 2011

Record last verified: 2011-08

Locations

BE (1)