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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males aged 18 to 55 years (inclusive).
- •Body mass index (BMI) of 18 to 30 kg/m
- •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.
排除标准
- •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
- •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-
- •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
- •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.
研究组 & 干预措施
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.
干预措施: ICA-105665 (Drug)
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.
干预措施: Ibuprofen (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: Capsaicin - Time 0, to 2 hours after injection. UV-B Pain: 2 hours post
次要结局
- UV-B: Heat pain,Laser Doppler Blood Flow(24 hours after irradiation)