Neuropathic pain.
Conditions
Interventions
Challege agent capsaicine.
Sponsors
Principal Investigator is Thijs Van Iersel
Eligibility
Inclusion criteria
Inclusion criteria: Eligible subjects must meet all of the following inclusion criteria: 1. Signed Informed Consent prior to any study related procedure; 2. Healthy, fair skinned, Caucasian subjects; 3. Aged between 18 and 55, extremes included, at screening; 4. No active, significant, acute or chronic illness as determined by past medical history and physical examination at screening; 5. Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study; 6. Sinus rhythm on 12-lead ECG.
Exclusion criteria
Exclusion criteria: Eligible subjects must meet none of the following exclusion criteria: 1. Test with an investigational drug within 3 months prior to the first dose; 2. Positive urine drug screen, alcohol breath test or pregnancy test (for females) at screening or day 1; 3. Known hypersensitivity to any of the contents of the study medication; 4. History or clinical evidence of any disease, and/or the existence of any surgical or medical condition, which might interfere with the study assessments such as diabetes, active or recent (one year) herpes zoster, neurological disease, significant dermatosis of the forearm; 5. History of clinical significant cardiac disease including arrhythmia; 6. Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening; 7. Clinically significant abnormal 12-lead ECG at screening; 8. Use of any medication, prescription or over-the-counter with an analgesic effect within 48 hours before the QST measurement or within 5 half-lives before the QST measurement, whichever is longer; 9. Legal incapacity or limited legal capacity at screening; 10. Any circumstances or conditions which, in the opinion of the investigator, may complicate or compromise the study, or the well being of the subject; 11. Employees of the investigator or study centre, as well as first grade family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local tolerability of QST battery. | — |
Secondary
| Measure | Time frame |
|---|---|
| (Local) tolerability of intra-dermal capsaicin. | — |
Contacts
Public ContactThijs Iersel, van
Xendo Drug Development BV Hanzeplein 1, Entrance 53
Outcome results
None listed