neuropathische pijn nerve pain neuropathic pain
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18 to 65 years (inclusive);;2. Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) and body weight between 50 kg and 90 kg (inclusive);;4. Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;;5. Subject is willing to comply with study restrictions
Exclusion criteria
Exclusion criteria: 1. Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator);;2. A semi recumbent systolic blood pressure of >150 mmHg and/or diastolic blood pressure of > 90 mmHg at screening;;3. History of alcoholism or substance abuse within three years prior to screening;;4. Positive pregnancy test;5. Male subjects habitually using more than 21 units of alcohol per week and female subjects using more than 14 units of alcohol per week;;6. Subject was a smoker or has used nicotine/nicotine-containing products within 3 months prior to screening;;7. Use of medication during the study period;;8 . Subject is unable to refrain from food and drinks containing a xanthine (e.g. chocolate, cola, coffee or tea) during the study days;9. Male subject is unable/unwilling to use a medically acceptable method of contraception throughout the entire study period. Female subject is not using oral contraceptives, or is not post-menopausal (last menstrual period > 2 years ago and FSH > 25 IU/L), or surgically sterilized;;10. Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;;11. Subject has a history of syncopal episodes;;12. Subjects that received a vaccination or immunization within the last month;;13. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year;;14. Subject has undergone major surgery within three months prior to screening;;15. Donation or loss of blood (> 500 mL) within 3 months prior to screening;;16. Inadequate venous accessibility as judged by clinicians (physician or nurse);;17. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of ARA 290 over time | — |
Secondary
| Measure | Time frame |
|---|---|
| none | — |
Countries
Netherlands
Outcome results
None listed