Status:
COMPLETED
Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is; to determine the pharmacodynamic (PD) effects of ICA-105665 using the intradermal (ID) capsaicin model in healthy male subjects, and to investigate the effect of ICA-1056...
Eligibility Criteria
Inclusion
- Healthy males aged 18 to 55 years (inclusive).
- 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
- Subject has had a clinically significant illness in the 4 weeks before screening.
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00962663
Start Date
August 1 2009
End Date
December 1 2009
Last Update
September 28 2012
Active Locations (2)
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1
Pfizer Investigational Site
Wythenshawe, Manchester, United Kingdom, M23 9QZ
2
Pfizer Investigational Site