- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02238717
Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints
December 15, 2014 updated by: Pfizer
A Double Blind, Double Dummy, Randomized, Placebo-controlled, 4 Period Cross-over Study To Examine The Effect Of Pf-06372865 On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin As A Positive Control
This study will examine the activity of 2 different doses of PF-06372865 on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
CL
-
Leiden, CL, Netherlands, 2333
- Centre for Human Drug Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
matching oral placebo
|
Active Comparator: Pregabalin
|
single oral dose (300mg)
|
Experimental: PF-06372865 (65mg)
|
single oral dose (65 mg)
|
Experimental: PF-06372865 (15mg)
|
single oral dose (15mg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Thermal pain detection threshold
Time Frame: 0.5 - 6 hours
|
0.5 - 6 hours
|
Ultra-violet light sensitized pain detection threshold
Time Frame: 0.5 - 6 hours
|
0.5 - 6 hours
|
Pressure pain tolerance threshold
Time Frame: 0.5 - 6 hours
|
0.5 - 6 hours
|
Electrical pain tolerance threshold
Time Frame: 0.5 - 6 hours
|
0.5 - 6 hours
|
Cold pressor tolerance threshold
Time Frame: 0.5 - 6 hours
|
0.5 - 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Electrical pain detection threshold
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Electrical pain area under the visual analogue scale pain curve
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Electrical pain post test visual analogue scale
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Electrical pain post-cold pressor pain detection threshold
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Electrical pain post cold pressor pain tolerance threshold
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Electrical pain post cold pressor area under the visual analogue scale curve
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Electrical pain post cold pressor post test visual analogue scale
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Conditioned pain modulation response pain detection threshold
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Conditioned pain modulation pain tolerance threshold
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Conditioned pain modulation area under the visual analogue scale curve
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Condition pain modulation post test VAS
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Pressure pain detection threshold
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Pressure pain area under the visual analogue scale curve
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Pressure pain post test visual analogue scale
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Cold pressor pain detection threshold
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Cold pressor area under the visual analogue scale curve
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Cold pressor post test visual analogue scale
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
PF-06372865 half life
Time Frame: 0.5 - 10 hours
|
0.5 - 10 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
September 4, 2014
First Submitted That Met QC Criteria
September 10, 2014
First Posted (Estimate)
September 12, 2014
Study Record Updates
Last Update Posted (Estimate)
December 16, 2014
Last Update Submitted That Met QC Criteria
December 15, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
- PF-06372865
Other Study ID Numbers
- B7431003
- 2014-003015-12 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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