To measure the plasma conc. of ARA 290 in healthy volunteers
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
neuropathische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma concentration of ARA 290 over time
Secondary outcome
none
Background summary
ARA290 is currently being used experimentally in the treatment of neuropathic
pain. The administration is either intravenously or subcutaneously. This
complicates the treatment process. In order to facilitate the administration,
the intranasal route is studied in this study. Should this succeed then this
route will be used in future clinical studies.
Study objective
To measure the plasma conc. of ARA 290 in healthy volunteers
Study design
Open, observational
Study burden and risks
The burden is low taken the results of previous studies. Benefit to the
participant is absent.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2012-005843-26-NL |
CCMO | NL43158.058.13 |