Multiple sclerosis psoriasis
Conditions
Sponsors
Forward Pharma GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about his participation and has given his/her informed consent in writing. 2. Subject is male or female, Caucasian, and in the age range between 18 and 55 years (inclusive). 3. Females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a highly effective (failure rate
Exclusion criteria
Exclusion criteria: 1. Subject shows clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, or clinical laboratory parameters (especially for leukocytes and differential count, liver enzymes, and serum creatinine) according to the Investigator*s judgment. 2. Has leukopenia (leukocyte count 0.75 x 109/L) or lymphocytopenia (count 139 or 89 or 90 beats/min. 7. Subject who donated blood (* 500 ml) or plasma (* 100 ml) or had a comparable blood loss (approximately 500 mL) during the last 3 months prior to start of this study and subject who donated more than 1.5 L of blood during the last 10 months prior to start of this study. 8. Subject with a known history of drug allergies or with a known allergy to any medicine chemically related to the study medication. 9. Subject who has had a clinically significant illness within 4 weeks prior to screening. 10. Subject with a history of chronic alcohol (regular intake of more than 35 g ethanol per day) or drug abuse within the last 6 months prior to first administration or evidence of such abuse as indicated by the laboratory profile conducted during the screening examination. 11. Subject who is demonstrating excess in xanthine consumption (more than 6 cups of coffee or equivalent per day). 12. Subject who has received prescription drugs or over-the-counter medication within 2 weeks prior to the first administration (with the exception of up to 1000 mg paracetamol per day). 13. Subject who received any investigational medication within 1 month prior to the first administration or has taken part in 4 (or more) other clinical trials within 10 months prior to the first administration. 14. Subject who received any treatment agents known to alter the major organs or systems within 1 month prior to the first administration (e.g., barbiturates, phenothiazines, cimetidine, etc.). 15. Subject shows positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus (HIV) I/II antibodies and antigen tests. 16. Male subjects and female subjects of childbearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate, i.e., less than 1% per year, when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner) [5]. Female subjects will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least 2 years. 17. Female subject who has
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic | — |
Secondary
| Measure | Time frame |
|---|---|
| Bioavailability of a delayed and slow-released DMF formulation; Safety and tolerability of FP187-V2B | — |
Countries
Netherlands
Outcome results
None listed