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.
- Conditions
- Painnerve excitability10034606
- Registration Number
- NL-OMON48588
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- 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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacodynamic endpoints:<br /><br>- Nerve excitability threshold endpoints<br /><br><br /><br><br /><br>For further information please see protocol page 36 and 37.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- PainCart endpoints<br /><br>- Intra-epidermal electrical stimulation endpoints<br /><br>- Tolerability / safety endpoints<br /><br><br /><br>Exploratory endpoints<br /><br>Pharmacokinetic analysis will only be performed if a relevant pharmacodynamic<br /><br>effect is observed. Data will be used for PK or PK-PD modelling. </p><br>