NL-OMON37233
Completed
Not Applicable
A study to investigate the pharmacodynamics, safety and tolerability of cutaneous capsaicin in healthy adult subjects. - Development of a nociceptive test battery - capsaicin models
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Small fibre neuropathy
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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).
Exclusion Criteria
- •\- 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;
Outcomes
Primary Outcomes
Not specified
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