A Phase 1 interventional study of PF-03049423 and PF-03049423 in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-09.
Sponsored by Pfizer · Phase 1 and Interventional
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.
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 581 completed or terminated interventional studies of FDA-regulated products, 380 (65%) have results posted.
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Exclusion Criteria:
Cohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers
Drug: PF-03049423
Placebo in oral solution, given once daily for 14 days
Drug: Placebo
PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers
PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers
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
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
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 in oral solution, given once daily for 14 days
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
Blood pressure
Time frame: Days 1 to 14
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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