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
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 April 22, 2014