Clinical trial NCT00962663: Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Capsaicin - Time 0, to 2 hours after injection. UV-B Pain: 2 hours post
Secondary outcomes:
measure: UV-B: Heat pain,Laser Doppler Blood Flow
timeFrame: 24 hours after irradiation
Other outcomes:
Locations:
city: Wythenshawe
country: United Kingdom
facility: Pfizer Investigational Site
state: Manchester
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: