To evaluate the overall safety and tolerability of intrathecally administered single ascending bolus doses of Xen2174 in healthy subjectsTo evaluate the effects of Xen2174, following its administration as a single intrathecal bolus, on EEG activity…
ID
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Brief title
Condition
- Other condition
Synonym
Health condition
Pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the overall safety and tolerability of intrathecally administered
single ascending bolus doses of Xen2174 in healthy subjects
Secondary outcome
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.
Background summary
Xen2174 is an investigational drug that is being developed to treat pain that
does not adequately respond to analgesic and is a peptide that binds to the
NorEpinefrine Transporter (NET) in the central nervous system, which is
involved in case of pain.
Study objective
To evaluate the overall safety and tolerability of intrathecally administered
single ascending bolus doses of Xen2174 in healthy subjects
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.
Study design
Seven groups of 5 male and infertile female subjects (20 in total) will take
part in this study. The study will comprise a medical screening (possibly
comprising various visits), one three-day stay at the Unit, two visits and
finally a follow-up visit.
Intervention
Per group of 5 subjects, 4 will recieve the investigational drug and 1 will
receive a placebo
Study burden and risks
The risks associated with this investigation are linked together with the
possible side effects of the intrathecal dosing and the investigational
product. The burden on the volunteer will continue to work with the recording
periods, venapunctions and the introduction of the cannulas. All volunteers are
closely monitored and supervised by experienced doctors and studystaff for
possible side effects.
Building 3 120 Meiers Road
Indooroopily, Queensland, 4068
Australië
Building 3 120 Meiers Road
Indooroopily, Queensland, 4068
Australië
Listed location countries
Age
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
• 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
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-014243-37-NL |
| CCMO | NL29372.040.09 |