Pain nerve excitability Pain
Conditions
Interventions
* mexiletine (namuscla) 333 mg,
* oral administration of lacosamide 300 mg.
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 the opinion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpoints: - Nerve excitability threshold endpoints For further information please see protocol page 36 and 37. | — |
Secondary
| Measure | Time frame |
|---|---|
| - PainCart endpoints - Intra-epidermal electrical stimulation endpoints - Tolerability / safety endpoints Exploratory endpoints Pharmacokinetic analysis will only be performed if a relevant pharmacodynamic effect is observed. Data will be used for PK or PK-PD modelling. | — |
Countries
Netherlands
Outcome results
None listed