Phase I , single-center, open-label, two-period study to investigate the pharmacokinetics of the DMF-containing formulation FP187-GC in healthy volunteers after oral administration in fasted and fed state
- Conditions
- Multiple sclerosispsoriasis10040790
- Registration Number
- NL-OMON43151
- Lead Sponsor
- Forward Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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 <1%) medically accepted contraceptive method during the investigational periods as well as 90 days after trial is finished such as:
- Systemic contraceptive (oral, implant, injection),
- Intrauterine device inserted for at least one month prior to trial entrance
- Sexual abstinence or vasectomized partner
4. Male subjects must agree to use a condom with spermicide or abstain from sexual intercourse throughout the trial (including washout intervals between treatment periods) until 90 days after the last dose of trial drug in the last treatment period.
OR
Have been surgically sterilized prior to inclusion.
AND
Agree not to donate sperm during participation in the trial and up to 90 days after follow-up visit.
5. Subject has a body weight of at least 50.0 kg and a body mass index in the range of 18.5 and 30.0 kg/m2 (inclusive) at screening.
6. Subject is non-smoker or smokes up to 10 cigarettes per day (or equivalent).
7. Subject shows negative alcohol breath test and drug urine test.
8. Subject is in good general health in the opinion of the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory parameters (hematology, clinical chemistry, and urinalysis). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
9. Standard liver function tests including ALT, AST, *-GT should not exceed the upper limit of normal for the local laboratory at Screening and Day -1 of Period 1. Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
10. Be willing and able to consume the entire high-calorie, high-fat breakfast meal in the designated timeframe required in the designated study period.
11. Subject is willing and able to comply with all conditions and requirements of the study.
12. Subjects who participated in a previous study investigating FP187 are allowed to participate in this study.
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 <3.5 x 109/L) or eosinophilia (count > 0.75 x 109/L) or lymphocytopenia (count <1.02 x 109/L) at screening and Day -1 of Period 1.
3. Has a creatinine value outside the normal range (female: <90 µmol/L; male: <110 µmol/L) and an estimated creatinine clearance (Cockcroft-Gault) <90 mL/min at screening and Day -1 of Period 1.
4. Subject with, or a history of clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
5. Subject who has a supine blood pressure at screening, after resting for at least 5 min: systolic blood pressure >139 or <90 mmHg, or diastolic blood pressure >89 or <55 mmHg.
6. Subject who has a supine pulse rate at screening, after resting for at least 5 min, outside the range of <50 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic</p><br>
- Secondary Outcome Measures
Name Time Method <p>Bioavailability of a delayed and slow-released DMF formulation;<br /><br>Safety and tolerability of FP187-GC</p><br>