Parkinson's disease Parkinson's disease, PD, alpha-synucleinopathy
Conditions
Interventions
Oral administration of MF1
D000284
MF1, Oral administration
Sponsors
Takeda Atsushi
Kawahata Ichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria (Parts A and B) 1) Healthy Japanese male adults aged >=18 and =18.5 and =40 and =18.5 and <32.0 kg/m2 at screening. 7) Female patients who are postmenopausal for at least one year at the time of informed consent, including menopause resulting from hysterectomy or oophorectomy. 8) Patients who have received sufficient explanation regarding the study from the principal investigator or subinvestigator, have understood the objectives of the study, voluntarily agreed to participate, and have provided written informed consent of their own free will.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (Parts A and B) 1) Subjects with clinically significant cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunological, endocrine, or psychiatric disorders, or any other abnormalities that may affect safety, increase seizure risk, lower seizure threshold, or confound study results. 2) Subjects with current or past diseases or surgical histories involving the gastrointestinal tract, liver, kidneys, or other organs that may affect drug absorption, metabolism, or excretion. 3) Subjects who used any medication, including over-the-counter drugs, within 7 days prior to the day before the first administration of the investigational product. 4) Subjects with seizure disorders such as epilepsy, or a history thereof. 5) Subjects with allergies or a history of allergies to drugs or foods. 6) Subjects with allergic predisposition who are considered unsuitable for participation by the principal investigator or subinvestigator. 7) Subjects with current or past alcohol or drug dependence. 8) Subjects who donated >=400 mL of whole blood within 12 weeks, >=200 mL of whole blood within 4 weeks, or blood components within 2 weeks prior to investigational product administration. 9) Subjects who tested positive at screening for HBs antigen, HCV antibody, HIV antigen/antibody, or syphilis serology (TP antibody test or RPR test). 10) Subjects unwilling to use appropriate contraception from the time of informed consent until the final study visit. 11) Subjects who answered "Yes" to Question 4 or 5 regarding suicidal ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, or who had a history of suicidal behavior within 6 months prior to screening. 12) Subjects who received investigational treatment in another clinical trial within 4 months prior to investigational product administration. 13) Subjects judged unsuitable for study participation by the principal investigator or subinvestigator based on findings from screening or admission assessments, observations, or examinations. Exclusion Criteria (Part C) 1) Patients with drug-induced parkinsonism, metabolic neurogenetic disorders, encephalitis, Parkinson-plus syndromes, or other atypical parkinsonian syndromes. 2) Patients with freezing of gait. 3) Patients with a history of stereotactic brain surgery for Parkinson's disease (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplantation). 4) Patients with clinically significant cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunological, endocrine, or psychiatric disorders other than Parkinson's disease, or any other abnormalities that may affect safety, increase seizure risk, lower seizure threshold, or confound study results. 5) Patients with current or past diseases or surgical histories involving the gastrointestinal tract, liver, kidneys, or other organs that may affect drug absorption, metabolism, or excretion. 6) Patients with seizure disorders such as epilepsy, or a history thereof. 7) Patients currently receiving antiplatelet agents or anticoagulants. 8) Patients with allergies or a history of allergies to drugs or foods. 9) Patients with allergic predisposition who are considered unsuitable for participation by the principal investigator or subinvestigator. 10) Patients with current or past alcohol or drug dependence. 11) Patients who donated >=400 mL of whole blood within 16 weeks, >=200 mL of w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Pharmacokinetics: The following analyses and summaries will be performed in the pharmacokinetic analysis set: - Summary statistics of plasma drug concentrations will be calculated by treatment group. - Summary statistics of pharmacokinetic parameters in plasma, urine, and cerebrospinal fluid (CSF) will be calculated by treatment group. - Dose proportionality after single administration, the effect of food, and accumulation following repeated administration will be evaluated. (2) Safety: The following analyses and summaries will be performed in the safety analysis set: - Adverse events - Frequency tabulations will be performed by treatment group, severity, and relationship to the investigational product. - Clinical laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) - Summary statistics and frequencies/proportions will be calculated by treatment group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics : For the pharmacodynamic analysis set, summary statistics for each exploratory endpoint will be calculated by treatment group. | — |
Contacts
Public ContactYu Nemoto
Tohoku University Hospital
Outcome results
None listed