A study to investigate the pharmacodynamics, safety and tolerability of cutaneous capsaicin in healthy adult subjects.
- Conditions
- Small fibre neuropathy10034606
- Registration Number
- NL-OMON37233
- 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
- Agree to and be capable of signing an informed consent form.
- Healthy male and female subjects;
- Age: 18 to 65 years at screening (inclusive);
- Body mass index between 18-30 kg*m-2 (inclusive);
- Able to refrain from strenuous physical exercise from 48 hours prior to admission and during each stay at the CHDR clinic;
- Able to refrain from use of all (methyl)xanthenes (e.g. coffee, tea, cola, chocolate) from 12 hours prior to admission and during each stay at the CHDR clinic;
- Able to refrain from alcohol use from 24 hours prior to admission and during each stay at the CHDR clinic;
- Ability to communicate well with the investigator in the Dutch language; and
- Ability for female subjects to attend study day 0 while in the follicular phase (3-13 days after onset of menstruation).
- Legal incapacity or inability to understand or comply with the requirements of the study;
- Clinically significant findings as determined by medical history taking, physical examination, ECG and vital signs;
- Hemodynamic status at screening: systolic <100 and >160 mmHg, diastolic <50 and >95 mmHg, heart rate <45 and >100 bpm measured on the non-dominant (non-leading/non-writing hand) arm;
- Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism), pain (disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy, etc.) or capsaicin (eczema, etc);
- Pregnancy;
- Dark skin (Fitzpatrick skin type V or VI), wide-spread acne, tattoos or scarring on back or upper leg;
- Subjects indicating nociceptive tests (including capsaicin formulation) intolerable or insensitive at screening;
- Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a positive alcohol breath test at screening;
- 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;
- History or clinical evidence of alcoholism or drug abuse;
- Smoking of >5 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each stay at the CHDR clinic;
- Use of prescription, illicit or herbal drugs within 7 days of nociceptive assessments;
- Use of over-the-counter medications within 3 days of nociceptive assessments; and/or
- Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Baseline demographics & personality<br /><br><br /><br>Immunogenicity<br /><br><br /><br>Pharmacodynamics Leg<br /><br>-Intra-epidermal nerve fibre density [IENFD]<br /><br>-Quantitative sensory testing [QST] (Leg PD)<br /><br>-Videothermography [VT] (Leg PD)<br /><br>-Laser Doppler blood flow [LDBF]<br /><br><br /><br>Pharmacodynamics Back<br /><br>-Heat-Capsaicin-Warmth Model (Back PD)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacodynamics PainCart<br /><br>- Nociceptive Pain Tasks<br /><br><br /><br>Potential for pain an discomfort associated with skin biopsies, pain tests and<br /><br>capsaicin applications. No benefit to the individual is expected.</p><br>