NL-OMON25429尚未招募不适用
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 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
研究概览
简要总结
A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
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