A Phase 1 interventional study of PF-04287881 and Placebo in Respiratory Tract Infections, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-04.
Sponsored by Pfizer · Phase 1 and Interventional
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 80 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PF-04287881 · Drug: Placebo
Drug: PF-04287881 · Drug: Placebo
Drug: PF-04287881 · Drug: Placebo
Drug: PF-04287881 · Drug: Placebo
Drug: PF-04287881 · Drug: Placebo
Drug: PF-04287881 · Drug: Placebo
Drug: PF-04287881 · Drug: Placebo
Japanese volunteers, low dose previously tested (based on PK)
Drug: PF-04287881 · Drug: Placebo
Japanese volunteers, intermediate dose previously tested (based on PK)
Drug: PF-04287881 · Drug: Placebo
Japanese volunteers, high dose previously tested (based on safety)
Drug: PF-04287881 · Drug: Placebo
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
Evaluation of safety and tolerability of PF-04287881 after single oral dose.
Time frame: Daily up to discharge, follow-up 7-10 days after dosing
Pharmacokinetics of PF-04287881 after a single oral dose.
Time frame: Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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