Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects
NCT ID: NCT00962663
Last Updated: 2012-09-28
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
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2009-08-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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ICA-105665
Three study drug treatments will be used: ICA-105665, ibuprofen, and placebo (for both ICA-105665 and Ibuprofen). The order of study drug treatment given to each subject during each specified treatment period is determined at randomization.
ICA-105665
Subjects randomized to receive ICA -105665 will receive 200 mg BID
Ibuprofen
Three study drug treatments will be used: ICA-105665, ibuprofen, and placebo (for both ICA-105665 and Ibuprofen). The order of study drug treatment given to each subject during each specified treatment period is determined at randomization.
Ibuprofen
Subjects randomized to receive Ibuprofen will receive placebo to ICA-105665 at all scheduled dosing times on Days 1 to 4 and a single dose of 800 mg Ibuprofen on the morning of Day 4.
Placebo
Three study drug treatments will be used: ICA-105665, ibuprofen, and placebo (for both ICA-105665 and Ibuprofen). The order of study drug treatment given to each subject during each specified treatment period is determined at randomization.
Placebo
Subjects randomized to receive placebo will receive placebo to ICA
-105665 at all scheduled dosing times on Days 1 to 4 and placebo to Ibuprofen on the morning of Day 4.
Interventions
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ICA-105665
Subjects randomized to receive ICA -105665 will receive 200 mg BID
Ibuprofen
Subjects randomized to receive Ibuprofen will receive placebo to ICA-105665 at all scheduled dosing times on Days 1 to 4 and a single dose of 800 mg Ibuprofen on the morning of Day 4.
Placebo
Subjects randomized to receive placebo will receive placebo to ICA
-105665 at all scheduled dosing times on Days 1 to 4 and placebo to Ibuprofen on the morning of Day 4.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 18 to 30 kg/m2.
* Non-smokers and smokers of up to 5 cigarettes or equivalent per day.
* Must be able to abstain from smoking during residential periods.
* Demonstration of positive hyperalgesia as defined by an area of hyperalgesia = 15 cm2 15 minutes after ID administration of 100 µg capsaicin.
* Demonstration of negative hyperalgesia as defined by an area of hyperalgesia \< 5 cm2 15 minutes after ID administration of capsaicin vehicle.
* Subject with a skin type compatible with the measures, and without significant skin allergies, pigmentary disorders, or any active dermatological conditions that might interfere with the conduct of the study.
Exclusion Criteria
* Use of prescribed medications and herbal supplements in the 7 days prior to dosing or over the counter preparations, including multivitamins and paracetamol, in the 48 h before dosing.
* Subject has a significant history of drug/solvent abuse (within 2 years prior to Day 1), or a positive drugs of abuse test at screening.
* Subject with a history of alcohol abuse or currently drinks in excess of 28 units per week (males), or has a positive breath alcohol test at the Screening visit or on Day 1.
* Subject has a Heat pain tolerance threshold (HPTT) of = 50°C at screening.
* Subjects who do not develop erythema at the highest intensity of UV-B light used to establish Minimum erythema dose (MED).
* Known allergy or intolerance to capsaicin or hot peppers.
* Subjects who have any skin trauma, scars or other skin disorder or tattoos on their forearms or on the front of their thighs.
* Subject with active chronic pain conditions or a history of chronic pain conditions.
* Any condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs.
* Previous ingestion of ICA-105665.
* Considering or scheduled to undergo any surgical procedure during the duration of the study.
* Prolonged QT/QTc interval (repeatedly = 450 msec). Received any agent known to alter hepatic or renal clearance (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, clarithromycin, troleandomycin, ketoconazole, miconazole, fluconazole, itraconazole, etc.) for a period of 30 days prior to Day 1.
* History of risk factors for Torsades de Pointes (family history of long QT syndrome, heart failure, hypokalemia).
* Subject is unable to tolerate being blindfolded.
* Subject has participated in a clinical study involving capsaicin within 1 year of the Screening visit.
* Subject has a history of skin cancer.
* Subject has a clinically significant history of anemia.
18 Years
55 Years
MALE
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Wythenshawe, Manchester, United Kingdom
Pfizer Investigational Site
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Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B5311006
Identifier Type: -
Identifier Source: secondary_id
ICA-105665-05
Identifier Type: -
Identifier Source: org_study_id