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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: ICA-105665 (Drug); Ibuprofen (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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-105665 on inflammatory hyperalgesia using the ultraviolet B (UV-B) model in healthy male subjects.

Clinical Details

Official title: A Randomized, Placebo-Controlled, 3-way Crossover Study to Investigate the Pharmacodynamic Effects of ICA-105665 Using the Intradermal Capsaicin and UV-B Models in Healthy Male Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Capsaicin: Visual Analogue Scale, hyperalgesia, allodynia, laser Doppler blood flow. UV-B pain assessments: Heat pain detection threshold, Heat pain tolerance threshold (HPTT), Laser Doppler blood flow (intensity and area), Skin temperature.

Secondary outcome: UV-B: Heat pain,Laser Doppler Blood Flow

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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.

Locations and Contacts

Pfizer Investigational Site, Unknown, Manchester M15 6SH, United Kingdom

Pfizer Investigational Site, Wythenshawe, Manchester M23 9QZ, United Kingdom

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2009
Last updated: September 27, 2012

Page last updated: August 20, 2015

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