Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679

Phase 1 Completed 32 enrolled Pfizer

RandomizedCrossoverQuadruple-blindBasic science

Summary

This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The second part (Part B) of this study will focus on the exploratory pharmacodynamics of PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses selected in Part B will have been administered previously in the Part A of the study.

Timeline

Start: 2011-05
Primary completion: 2011-09
Completion: 2011-09

Publications

Winchester WJ, Gore K, Glatt S, Petit W, Gardiner JC, Conlon K, Postlethwaite M, Saintot PP, Roberts S, Gosset JR, Matsuura T, Andrews MD, Glossop PA, Palmer MJ, Clear N, Collins S, Beaumont K, Reynolds DS. Inhibition of TRPM8 channels reduces pain in the cold pressor test in humans. J Pharmacol Exp Ther. 2014 Nov;351(2):259-69. doi: 10.1124/jpet.114.216010. Epub 2014 Aug 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	PF-05105679	Small molecule	600 mg	—
Comparator	PF-05105679	Small molecule	900 mg	—

Indications

No indication recorded.