*A randomized, double-blind, placebo-controlled Phase I study to evaluate the safety and tolerability of intrathecally administered single ascending bolus doses of Xen2174 in healthy subjects*
- Conditions
- PijnPain
- Registration Number
- NL-OMON32600
- Lead Sponsor
- Xenome Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
• you have given your written consent to take part in this study;
• you are between 21 and 55 years of age (inclusive);
• you are in good physical and mental health;
• your body weight must be appropriate in relation to your height;
• for female volunteers: you are not pregnant, nor can you get pregnant (you are surgically sterile or your uterus has been removed or you have been post-menopausal - if you are over 50 years old, your last menstrual period must be at least one year ago; if you are 50 years or younger, your last menstrual period must be more than two years ago);
• no abnormalities are diagnosed during the screening.
• you drink more than 21 (male) or 14 (female) units of alcohol per week;
• you are (or have been) taking illegal drugs and/or are (or have been) using alcohol to excess;
• you have used prescribed medication in the 7 days before admission;
• you have used over the counter medication in the 7 days before admission (exception paracetamol);
• you have used medication, which makes you unsuitable to participate in this study;
• females: if you are pregnant or lactating;
• you have an abnormal EEG at screening or in the past;
• you have taken part in another clinical drug study during the last 3 months prior to the study;
• you have donated blood in the three months before admission;
• you are Hepatitis B, C or HIV positive;
• you or your releatives have or had epilepsy;
• you have lost you consciences in the past (exception fainting);
• you have had several blow to the head which could lead to brain damage;
• you had meningitis or any other dissease that could be of influence on the brain;
• you had chemotherapy or radiotherapy;
• you have a bood difficiency;
• you or your relatives have had a back abnormality, which makes you unsuitable to participate in this study;
• you had an operation to the back, which makes you unsuitable to participate in this study;
• you have a skin abnormality at the injection site;
• you have received Xen2174 in the past;
• you have a clinically significant medicine allergy or sensitivity;
• you are not suitable to participate in this study according to the investigator;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the overall safety and tolerability of intrathecally administered<br /><br>single ascending bolus doses of Xen2174 in healthy subjects<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the effects of Xen2174, following its administration as a single<br /><br>intrathecal bolus, on EEG activity (continuously until 24 hours post-dose, and<br /><br>at selected intervals thereafter through the final follow-up visit)<br /><br>To analyze plasma concentrations of Xen2174 at selected time points.</p><br>