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Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin

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NCT01127906

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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.
Show details

- Healthy volunteers.

- Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.

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

- Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy).

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half-lives preceding the first dose of study
medication.

- Subjects with inadequate cardiac function (ECG demonstrating prolonged QTc interval at
screening).

- Subjects with inadequate or excessive sensitivity to UVB light.

NCT01127906
Pfizer
Completed
Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin

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[email protected]

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Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin
A Randomized, Double-Blind, Double-Dummy, Placebo And Active Comparator Controlled 4-Period Cross-Over Study To Assess The Effect Of PF-04531083 On Heat Pain In The UVB-Induced Pain Model In Healthy Volunteers
PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-04531083 100mg
    Oral PF-04531083 100mg suspension single dose
  • Drug: PF-04531083 2000mg
    Oral PF-04531083 2000mg suspension single dose
  • Drug: Placebo suspension
    Oral Placebo suspension (matched to PF-04531083 suspension)
  • Drug: Placebo tablet
    Oral Placebo tablet (matched to Oxycodone)
  • Drug: Oxycodone 20mg
    Oral Oxycodone 20mg (Oxycontin) controlled release formulation
Randomized cross-over sequence
Randomized unbalanced sequence of incomplete block design with replicates within sequence
Interventions:
  • Drug: PF-04531083 100mg
  • Drug: PF-04531083 2000mg
  • Drug: Placebo suspension
  • Drug: Placebo tablet
  • Drug: Oxycodone 20mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers.
  • Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.

Exclusion Criteria:

  • Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy).
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • Subjects with inadequate cardiac function (ECG demonstrating prolonged QTc interval at screening).
  • Subjects with inadequate or excessive sensitivity to UVB light.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01127906
B1351003
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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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1-800-718-1021

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[email protected]



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