NL-OMON42906CompletedNot Applicable
A randomized, open-label, four-way cross-over, single dose study to compare the pharmacokinetics of monomethyl fumarate and other metabolites after administration of dimethyl fumarate as a delayed- and slow-release formulation of FP187 and Tecfidera® in healthy volunteers. - PK comparison of DMF as a FP187 formulation and Tecfidera®
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Forward Pharma GmbH
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Eligible subjects must meet all of the following inclusion criteria at screening:
- •1. Is informed and given ample time and opportunity to think about participation and has given his/her informed consent in writing.
- •2. Is a healthy Caucasian male or female aged between 18 and 55 years (inclusive) at screening.
- •3. Is in good general health in the opinion of the Investigator, as determined by absence of evidence of any active or chronic disease following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory parameters (hematology, blood 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.
- •4. Is a female with childbearing potential and is either surgically sterile (hysterectomy or tubal ligation) or uses 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:
- •o Systemic contraceptive (implant, injection),
- •o Intrauterine device inserted for at least one month prior to trial entrance,
- •o Sexual abstinence or vasectomized partner;
- •5. Is a male subjects who agrees to use a condom 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.
- •Agrees not to donate sperm during participation in the trial and up to three months after follow-up visit.
- •Has been surgically sterilized prior to inclusion.
- •6. Has a body weight of at least 50 kg and a body mass index between 18.5 - 30.0 kg*m2 (inclusive) at screening.
- •7. Is non-smoker or smokes up to ten cigarettes per day (or equivalent) and willing to abstain smoking during the in house period.
- •8. Shows a negative alcohol breath test and drug urine test.
- •9. Has the ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions.
Exclusion Criteria
- •Eligible subjects must meet none of the following exclusion criteria at screening:
- •1. Has legal incapacity or inability to understand or comply with the requirements of the study.
- •2. Has 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. In the case of uncertain or questionable results, tests performed during screening may be repeated once before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- •3. Has leukopenia (leukocyte count <3.5 x 10*9/L) or eosinophilia (count > 0.75 x 10*9/L) or lymphocytopenia (count <1.02 x 10*9/L) at screening and Day -1 of Period 1.
- •4. Has a creatinine value outside the normal range (female: <90 *mol/L; male: <110 *mol/L) and an estimated creatinine clearance (Modification of Diet in Renal Disease) <90 mL/min at screening and Day -1 of Period 1.
- •5. Has standard liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (*-GT) exceeding 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.
- •6. Has a history or symptoms of any clinically significant neurologic, gastrointestinal (including surgical (abdominal) interventions likely influencing medication absorption), renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
- •7. 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.
- •8. Has a supine pulse rate at screening, after resting for at least 5 min, outside the range of <45 or >90 beats/min.
- •9. Has Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core antibody (anti-HBcore), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- •10. Has any significant allergic reactions (urticarial, rash, or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
- •11. Has a history of chronic alcohol (regular intake of more than three units per day) or drug abuse within the last six months prior to first administration or evidence of such abuse as indicated by the laboratory profile conducted during the screening examination. Alcohol consumption will be prohibited during study confinement and at least 24 hours before screening, before dosing, and before each scheduled visit.
- •12. Is demonstrating excess in xanthine consumption (more than eight cups of coffee or equivalent per day
- •13. Uses any medications (prescription or over-the-counter (OTC)) within 21 days of study drug administration, or less than five half-lives (whichever is longer). Exception is paracetamol (up to 4000 mg/day). Other exceptions will only be made if the rationale is discussed with the Principal Investigator and clearly documented.
- •14. Received any treatment agents known to alter the major organs or systems within one month prior to the first administration (e.g., barbiturates, phenothiazines, cimetidine, etc.).
- •15. Participated in an investigational drug or device study within three mo
Investigators
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