Vasodilation, Pain Neuropathic pain
Conditions
Interventions
Challenge drugs
25 *L of 15% allyl isothiocyanate solution in mineral oil applied topically to
the skin within an O-ring or using a silicone square mall (3x3 cm, for
applications on the back) for 30
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects *18 and *65 years of age. 2. Signed informed consent before any study procedures.
Exclusion criteria
Exclusion criteria: 1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance. 2. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). 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. 3. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at screening. 4. Use of any medications (prescription or over the counter [OTC]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer). Paracetamol (up to 4 g/day) and ibuprofen (up to 1g/day) are not allowed within 2 days before screening and before each study drug administration. Exceptions will only be made if the rationale is clearly documented by the investigator. 5. Use of any 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 clearly documented by the investigator. 6. Participation in other investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study or dosed >3 times in the year prior to first dosing of this study). 7. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any other addictive agent 8. Positive test for drugs of abuse at screening. 9. Alcohol will not be allowed from 24 hours before screening or study days. 10. Smoking (i.e., smoking of any cigarettes within 3 months of study participation). Minor deviations may be accepted if judged by the investigator to have no clinical relevance. 11. Excess of caffeine consumption (more than eight cups of coffee or equivalent per day) 12. Known allergy to mustard oil, or any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or food component, or multiple drug allergies (non-active hay fever is acceptable), or (history of) contact allergies, or history of atopic dermatitis, or history of food allergies. 13. Loss or donation of blood over 500 mL within three months prior to screening or intention to donate blood or blood products during the study. 14. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease. 15. Any skin disorders, excessive hair growth, tattoos, or other phys
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laser speckle basal flow (AU) after * AITC administration * AITC in combination with whole body heating | — |
Secondary
| Measure | Time frame |
|---|---|
| * Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit * Concomitant medication throughout the study at every study visit * VAS pain and itch scores * Serum nitrite, nitrate and peroxynitrite concentrations * Multispectral camera parameters * Clinician Erythema Assessment scale * Skin colorimetry parameters * Cold pain detection threshold (PDT) * Heat PDT * Pressure PDT | — |
Countries
Netherlands
Outcome results
None listed