A randomized, double-blind, double-dummy, placebo-controlled, three-way crossover study to investigate the effects of mexiletine and lacosamide on nerve excitability and evoked pain tests in healthy subjects

•Centre for Human Drug Research, Leiden0 sites18 target enrollmentTBD

Conditions•Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: •Pain
Sponsor: •Centre for Human Drug Research, Leiden
Enrollment: 18
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

•Centre for Human Drug Research, Leiden

Eligibility 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

•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.