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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ICA-105665; Drug: Placebo; Drug: Ibuprofen

• Registration Number: NCT00962663
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ICA-105665	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.
Placebo	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.
Ibuprofen	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.

Primary Outcome Measures

Name	Time	Method
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.	Capsaicin - Time 0, to 2 hours after injection. UV-B Pain: 2 hours post

Secondary Outcome Measures

Name	Time	Method
UV-B: Heat pain,Laser Doppler Blood Flow	24 hours after irradiation

Trial Locations

Locations (1)

Pfizer Investigational Site