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Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Wythenshawe, Manchester, M23 9QZ United Kingdom
Contact
1-800-718-1021
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.
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- 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00962663
Pfizer
Completed
Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects

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Pfizer Clinical Trials Contact Center

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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