Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679
SINGLE DOSE
A Phase I, Randomized, Placebo-Controlled, Dose Escalating Cross Over Study To Evaluate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of PF-05105679 Under Fasted Conditions In Healthy Volunteers
1 other identifier
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 3, 2011
September 1, 2011
4 months
May 23, 2011
September 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events as a measure of safety and tolerability.
3 days
Pharmacokinetics of single doses of PF-05105679 as measured by plasma concentrations- Cmax, Tmax, half life, AUC last, AUC(0-24) and MRT
3 days
Secondary Outcomes (4)
Average AUC2min VAS (cold pressor test) of PF-05105679.
24 hours
Cold detection threshold (°C) of PF-05105679.
24 hours
Cold pain threshold (°C) of PF-05105679.
24 hours
Stimulus-response function to cold stimuli following menthol application.
24 hours
Study Arms (3)
Cohort 1: Experimental intervention: PF-05105679 or placebo
EXPERIMENTALCohort 1
Cohort 2: Experimental intervention: PF-05105679 or placebo
EXPERIMENTALCohort 2
Cohort 3: Experimental intervention PF-05105679 or placebo and
ACTIVE COMPARATORCohort 3
Interventions
Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679
Eligibility Criteria
You may qualify if:
- Healthy Volunteers
You may not qualify if:
- Standard Healthy Volunteers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, B-1070, Belgium
Related Publications (1)
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.
PMID: 25125580DERIVED
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2011
First Posted
July 13, 2011
Study Start
May 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 3, 2011
Record last verified: 2011-09