Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679 (SINGLE DOSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01393652
First received: May 23, 2011
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: PF-05105679
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of single doses of PF-05105679 as measured by plasma concentrations- Cmax, Tmax, half life, AUC last, AUC(0-24) and MRT [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average AUC2min VAS (cold pressor test) of PF-05105679. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Cold detection threshold (°C) of PF-05105679. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Cold pain threshold (°C) of PF-05105679. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Stimulus-response function to cold stimuli following menthol application. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Experimental intervention: PF-05105679 or placebo
Cohort 1
Drug: PF-05105679
Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679
Other Name: Not specified
Experimental: Cohort 2: Experimental intervention: PF-05105679 or placebo
Cohort 2
Drug: PF-05105679
Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679
Other Name: Not specified
Active Comparator: Cohort 3: Experimental intervention PF-05105679 or placebo and
Cohort 3
Drug: PF-05105679
Subject will be randomized to a treatment sequence, and assigned to placebo, 2 separate single doses of PF-05105679 in the fasted state and to controlled-release Oxycodone 20 mg (positive control) , with at least one week wash-out between doses.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy Volunteers

Exclusion Criteria:

Standard Healthy Volunteers

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393652

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01393652     History of Changes
Other Study ID Numbers: B3351001
Study First Received: May 23, 2011
Last Updated: September 30, 2011
Health Authority: Belgium: Belgium Health Authority

Keywords provided by Pfizer:
Pharmacokinetics Safety Tolerability Pharmacodynamics

ClinicalTrials.gov processed this record on October 30, 2014