Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: Ibuprofen
Drug: ICA-105665
Drug: Placebo
Details and patient eligibility
About
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.
Enrollment
25 patients
Sex
Male
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
25 participants in 3 patient groups, including a placebo group
ICA-105665
Experimental group
Description:
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.
Treatment:
Drug: ICA-105665
Ibuprofen
Active Comparator group
Description:
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.
Treatment:
Drug: Ibuprofen
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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