To measure the PK of ARA290 when given in de SQ form
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma concentration of ARA290
Secondary outcome
NA
Background summary
We recently studied ARA290 in neuropathic pain patients (with sacrcoidosis and
DM). The results of the first open label study were very positive finding a
high response rate (55-60%) with pain relief > 50% during the treatment period
(P10.131). No side effects occurred. The only drawback to the treatment was the
need for the intravenous treatment. This is cumbersome, and needs a doctor or
nurse present during treatment. Araim Pharmaceuticals therefore decided to
develop a subcutaneous formulation which allows the patient to dose him or
herself without the need for an intravenous access line. Similar to insulin
treatment the patient can administer the ARA290 via a SQ (subcutaneous
injection). In the current study we will assess the pharmacokinetics of ARA290
given in the subcutaneous formulation and compare this to an intravenous
injection in a small group of volunteers.
Study objective
To measure the PK of ARA290 when given in de SQ form
Study design
Open label
Cross-over
Study burden and risks
Minimal if any
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers in the age range of 18-65 years
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. Negative 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 | EUCTR2012-000390-23-NL |
| CCMO | NL39602.058.12 |