Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin
NCT ID: NCT01127906
Last Updated: 2010-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2010-06-30
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Randomized cross-over sequence
Randomized unbalanced sequence of incomplete block design with replicates within sequence
PF-04531083 100mg
Oral PF-04531083 100mg suspension single dose
PF-04531083 2000mg
Oral PF-04531083 2000mg suspension single dose
Placebo suspension
Oral Placebo suspension (matched to PF-04531083 suspension)
Placebo tablet
Oral Placebo tablet (matched to Oxycodone)
Oxycodone 20mg
Oral Oxycodone 20mg (Oxycontin) controlled release formulation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-04531083 100mg
Oral PF-04531083 100mg suspension single dose
PF-04531083 2000mg
Oral PF-04531083 2000mg suspension single dose
Placebo suspension
Oral Placebo suspension (matched to PF-04531083 suspension)
Placebo tablet
Oral Placebo tablet (matched to Oxycodone)
Oxycodone 20mg
Oral Oxycodone 20mg (Oxycontin) controlled release formulation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.
Exclusion Criteria
* 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.
18 Years
55 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pfizer, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Brussels, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B1351003
Identifier Type: -
Identifier Source: org_study_id