Pharmacological effects on nerve excitability in healthy volunteers
- Conditions
- •Pain
- Registration Number
- NL-OMON25429
- Lead Sponsor
- •Centre for Human Drug Research, Leiden
- Brief Summary
A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
1. Signed informed consent prior to any study-mandated procedure
2. Healthy male subjects, 18 to 45 years of age, inclusive at screening.
3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening and with a minimum weight of 50 kg. .
4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the
study restrictions.
5. All subjects must practice effective contraception during the study and be willing and able to continue
contraception for at least 90 days after their last dose of study treatment.
1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of which might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in theopinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-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). Subjects with pre-dose findings of clinically significant changes in electrolytes should be excluded. 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. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
8. Participation in an investigational drug or device study within 3 months prior to first dosing, or for more than 4 times a year
17. 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) or pain (disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy, etc.).
18. Subjects indicating pain tests intolerable at screening or achieving tolerance at >80% of maximum input intensity for any pain test for cold, pressure and electrical tests.
19. History or presence of post-inflammatory hyperpigmentation.
20. Dark skin (Fitzpatrick skin type IV, V or VI), widespread acne, freckles, tattoos or scarring on the back.
22. History of trauma to the upper extremities or other orthopaedic conditions that, in the opinion of the
investigator, could affect the electrophysiological measurements.
23. History of (or symptoms indicating presence of) carpal tunnel syndrome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacodynamic endpoints:<br>- Nerve excitability threshold endpoints<br>
- Secondary Outcome Measures
Name Time Method PainCart endpoints<br>- lntra-epidermal electrical stimulation endpoints<br>- Tolerability / safety endpoints<br>Exploratory endpoints<br>Pharmacokinetic analysis will only be performed if a relevant pharmacodynamic effect is observed. Data will be used for PK or<br>PK-PD modelling.<br>