NL-OMON45379已完成不适用
Validation of the capsaicin (1%) sensitization model in the context of the PainCart test battery - Capsaicin validation study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Healthy male subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs and urinanalysis.
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
- •3. Able to participate and willing to give written informed consent and to comply with the study restrictions.;Part B
- •1. Healthy male subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead Electrocardiogram (ECG), haematology, blood chemistry, and urinalysis
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
- •3. Able to participate and willing to give written informed consent and to comply with the study restrictions.
排除标准
- •1. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
- •2. Positive test for drugs of abuse at screening or pre-dose. Positive tests at screening may be repeated once.
- •3. Use of any medications (prescription or over-the-counter [OTC]), vitamin, mineral, herbal, and dietary supplements within 14 days prior to first study day, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is discussed and clearly documented by the Investigator.
- •4. Clinically significant abnormalities, as judged by the Investigator. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- •5. Participation in an investigational drug or device study within 3 months prior to screening.
- •6. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
- •7. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against capsaicin specific
- •8. Dark skin (Fitzpatrick skin type V - VI), wide-spread acne, tattoos or scarring on the volar forearm.
- •9. Subject indicating a Numeric Rating Scale (NRS)(0-10) of more than 8 at screening after administration of capsaicin.
- •10. Smoker of more than 10 cigarettes per day prior to Screening or who use tobacco products equivalent to more than 10 cigarettes per day.
- •11. Consume, on average, >8 units/day of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) and not able to refrain from use during each stay at the CHDR clinic.
- •12. Unwillingness or inability to comply with the study protocol for any other reason.
- •13. Subject indicating prekindling process intolerable ;Part B
- •1. Positive test for drugs of abuse at screening or pre-dose. Positive tests at screening may be repeated once.
- •2. History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited during study confinement and at least 24 hours before screening, before dosing, and before each scheduled visit.
- •3. History or clinical evidence of alcoholism or drug abuse.
- •4. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
- •5. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- •6. Systolic blood pressure (SBP) greater than 145 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg.
- •7. Use of any medications (prescription or over-the-counter [OTC]), vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is discussed and clearly documented between the Investigator and the sponsor.
- •8. Clinically significant abnormalities, as judged by the Investigator, in laboratory t
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