A Phase 1 interventional study of PF-3864086 and Placebo in Pain, sponsored by Pfizer. Completed at 1 site in Belgium. Open to male participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-08.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
The purpose of this study is to determine the safety and tolerability of PF-03864086 in healthy male human volunteers. Determine the pharmacokinetics (calculations of the rate of elimination of PF-03864086 from the body once the compound is ingested).
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Drug: PF-3864086
Drug: Placebo
The dosage form is POS (powdered oral suspension). Each subject will have 5 periods and the frequency (and duration) is once per period. The doses have been left flexible within the protocol but are listed as: 3, 10, 30, 60, 120, 240, 480 and 720 mg with an option to insert an additional dose cohort as well.
Placebo
Pharmacokinetics
Time frame: measured intensively in the first 48 hours and continue out to day 14
Tolerability
Time frame: measured intensively in the first 48 hours and continue out to day 14
Temperature change
Time frame: continuous recording over the first 48h post dose
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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