Healthy volunteers (intended indication: pain) MedDRA version: 20.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Sponsors
Aarhus University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and regimens and availability for the duration of the study Caucasian male or female subjects, aged 18 years to 45 years Subjects must be in good health as determined by the medical history, physical and laboratory examinations and must not show any clinically significant deviations from reference ranges as determined by 12-lead electrocardiogram (ECG), vital signs (blood pressure, pulse rate and respiratory rate) and laboratory parameters (renal and hepatic function) Body mass index >18 kg/m2 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Presence of any medical devices (e.g., cardiac pacemaker), implants or protheses unless it is beyond discussion that these will not put the subject’s safety during the study at risk and will not interfere with the results of the study Known or suspected allergic reactions / hypersensitivity to components of lacosamide/Vimpat®. Second- or third-degree atrioventricular (AV) block. Known or suspected allergic reactions / hypersensitivity to components of pregabalin/Lyrica®. Known or suspected allergic reactions / hypersensitivity to components of tapentadol / Palexia®. Known contraindication for drugs with µ-opioid agonist activity, i.e., significant respiratory depression, acute or severe bronchial asthma or hypercapnia. Present or suspected paralytic ileus. Acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs. Not willing or able to abstain from changes in physical exercise activities during the Study. Any chronic pain condition or recent (i.e. within the preceding 2 years) history thereof. Migraine (at least 1 attack in the last 24 months). Recurrent headache or back pain on more than 5 days/month in the last 3 months. Caffeine consumption of more than 8 servings of coffee, tea, or other caffeinated drinks per day. Each serving is approximately 120mg of caffeine. Any relevant symptom of neurological dysfunction of the motor and sensory system that may interfere with the conduct of the study. Clinically-evident psychiatric diseases (e.g. depression, anxiety). History or symptoms of central nervous system disease or peripheral nerve lesions or dysfunction with sequelae that may impact the study assessments or that may deteriorate by one dose of a drug with anti-epileptic, noradrenergic or opioid activity. Focused neurological examination showing signs of abnormality. Active internal disease or sequelae of internal disease (e.g. diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases, hypo- or hyperthyroidism, hypertension etc.). Diseases or conditions known to interfere with the distribution, metabolism, or excretion of drugs. Clinically significant disease (e.g. medical history of infection with human immunodeficiency virus (HIV) Type 1 or Type 2, hepatitis B, or hepatitis C) or condition that may affect efficacy or safety assessments, or any other reasons which, in investigator´s opinion, may preclude the subject´s participation in the trial. Not willing or able to abstain from alcohol from 48 hours prior to any study period and until the end of the study period. Consumption of cannabis in the last 4 weeks prior to the study. Evidence or history of alcohol or drug (opioids, amphetamines, benzodiazepines, cannabinoids) abuse (as defined by ICD-10 or DSM IV) including positive or missing drugs of abuse screen (urine drugs of abuse test). Consumption of more than 21 alcohol units per week for male subjects and more than 14 units per week for female subjects (1 alcohol unit = 1 beer [12 oz/355 mL] = 1 wine [5 oz/150 mL] = 1 liquor [1.5 oz/40 mL] = 0.75 oz/20 mL alcohol). Habitually smoking more than 10 cigarettes, 2 cigars, or 2 pipes of tobacco per day within the last 6 months before enrollment in this trial. Known or suspected of not being willing or able to comply with the requirements of the trial protocol or the instructions. Inability to communicate meaningfully with the trial site staff (e.g. insufficient language skills). Any person with di
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To test if the Strength Duration Time Constant (SDTC) changes (at planned first post-dose timing) of large sensory fibers differs in the lacosamide period as compared to the placebo period. 2. To test if the Strength Duration Time Constant (SDTC) changes (at planned first post-dose timing) of large motor fibers differs in the lacosamide period as compared to the placebo period. ;Secondary Objective: 1. To test if the SDTC changes (at planned first post-dose timing) of large sensory fibers differs in the pregabalin and/or tapentadol periods as compared to the placebo period 2. To test if the SDTC changes (at planned first post-dose timing) of large motor fibers in the pregabalin and/or tapentadol periods differs as compared to the placebo period. 3. To test if the SDTC changes (at planned first post-dose timing) of small sensory fibers differs in the lacosamide period as compared to the placebo period.;Primary end point(s): Changes of the Strength Duration Time Constant (SDTC) measured in large sensory fibers and in large motor fibers on the non-sensitized skin;Timepoint(s) of evaluation of this end point: At the planned first PD time point post dosing relative to their pre-dose PD measurement (i.e. difference to period specific baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Strength Duration Time Constant (SDTC) measured in small sensory fibers ;Timepoint(s) of evaluation of this end point: At the planned first PD time point post dosing relative to their pre-dose PD measurement (i.e. difference to period specific baseline). | — |
Countries
Belgium, Denmark, Germany, Italy
Contacts
Public ContactDanish Pain research Center
Aarhus University
Outcome results
None listed