Pijn Pain
Conditions
Interventions
Per group of 5 subjects, 4 will recieve the investigational drug and 1 will
receive a placebo
Sponsors
Xenome Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the overall safety and tolerability of intrathecally administered single ascending bolus doses of Xen2174 in healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of Xen2174, following its administration as a single intrathecal bolus, on EEG activity (continuously until 24 hours post-dose, and at selected intervals thereafter through the final follow-up visit) To analyze plasma concentrations of Xen2174 at selected time points. | — |
Countries
Netherlands
Outcome results
None listed