Interventional study to assess local pharmacodynamics and tolerability of topical allyl isothiocyanate in healthy male subjects.
- Conditions
- Vasodilation, PainNeuropathic pain
- Registration Number
- NL-OMON50731
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Healthy male subjects *18 and *65 years of age.
2. Signed informed consent before any study procedures.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Laser speckle basal flow (AU) after<br /><br>* AITC administration<br /><br>* AITC in combination with whole body heating</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at<br /><br>every study visit<br /><br>* Concomitant medication throughout the study at every study visit<br /><br>* VAS pain and itch scores<br /><br>* Serum nitrite, nitrate and peroxynitrite concentrations<br /><br>* Multispectral camera parameters<br /><br>* Clinician Erythema Assessment scale<br /><br>* Skin colorimetry parameters<br /><br>* Cold pain detection threshold (PDT)<br /><br>* Heat PDT<br /><br>* Pressure PDT</p><br>