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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Healthy Volunteers

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Standard Healthy Volunteers

NCT01393652
Pfizer
Completed
Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679

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Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy Volunteers
  • 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
  • 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.
  • Experimental: Cohort 1: Experimental intervention: PF-05105679 or placebo
    Cohort 1
    Intervention: Drug: PF-05105679
  • Experimental: Cohort 2: Experimental intervention: PF-05105679 or placebo
    Cohort 2
    Intervention: Drug: PF-05105679
  • Active Comparator: Cohort 3: Experimental intervention PF-05105679 or placebo and
    Cohort 3
    Intervention: Drug: PF-05105679
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy Volunteers

Exclusion Criteria:

Standard Healthy Volunteers

Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01393652
B3351001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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