Tremor in Parkinsons disease
Conditions
Interventions
Part A: DSP-0551 14 mg, 40 mg, 100 mg, 200 mg, 400 mg, 600 mg, 750 mg
Part B: DSP-0551 200 mg
Part C: DSP-0551 200 mg
Part D: DSP-0551 200 mg, 750 mg
Part E: Zonisamide 50 mg, 200 mg, 400 mg
Part F: D
Sponsors
Hironobu Tsukada
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion in the clinical trial is limited to cases that meet all of the following criteria. For criteria where a specific part name is designated, only that part will be considered. Age and target 1) Participants meeting all of the following criteria - Part A, Parts D-F: A healthy Japanese adult male between the ages of 18 and 50 at the time of signing the Informed Consent Document (ICF). - Part B: Males: Healthy Japanese males aged 65 to 80 at the time of ICF signing. Females: Healthy postmenopausal Japanese females aged 65 to 80 at the time of ICF signing, with no menstrual period for at least 12 months. Weight and BMI 2) Males: At the time of screening, weight must be between 50.0 kg and 90.0 kg, and BMI must be between 18.5 and less than 30.0. Females: At the time of screening, weight must be between 45.0 kg and 80.0 kg, and BMI must be between 17.6 and less than 30.0 . "BMI = weight (kg) / [height (m)]2" Inclusion in the clinical trial is limited to cases that meet all of the following criteria. For criteria where a specific part name is designated, only that part will be considered. Age and target 1) Participants meeting all of the following criteria - Part A, Parts D-F: A healthy Japanese adult male between the ages of 18 and 50 at the time of signing the Informed Consent Document (ICF). - Part B: Males: Healthy Japanese males aged 65 to 80 at the time of ICF signing. Females: Healthy postmenopausal Japanese females aged 65 to 80 at the time of ICF signing, with no menstrual period for at least 12 months. Weight and BMI 2) Males: At the time of screening, weight must be between 50.0 kg and 90.0 kg, and BMI must be between 18.5 and less than 30.0. Females: At the time of screening, weight must be between 45.0 kg and 80.0 kg, and BMI must be between 17.6 and less than 30.0 "BMI = weight (kg) / [height (m)]2" Requirements for contraception, etc. 3) Part A, Part B, Part D, Part F: Individuals who agree to practice sexual abstinence as part of their lifestyle or to use appropriate contraception from the time of signing the ICF until 30 days after the last dose of the investigational drug Obtaining consent 4) Individuals who are able to sign the ICF in accordance with the procedure in Section 10.1.3 and who can comply with the requirements and limitations set forth in the ICF and this clinical trial protocol. Other selection criteria 5) Individuals who possess the necessary educational qualifications to communicate effectively with staff at the clinical trial site, including the physician in charge, and who can report their own symptoms.
Exclusion criteria
Exclusion criteria: If any of the following criteria are met, the participant will be excluded from the clinical trial. Medical condition 1) Individuals who fall under the following categories - Part A, Parts D-F: Individuals with a history of cardiovascular disease, liver disease, kidney disease, endocrine disease, digestive disease, hematological disease, respiratory disease, central nervous system or neuropsychiatric disorder (including seizure-related disorders (e.g., Parkinson disease), epilepsy, essential tremor, and writer's cramp), skin disease, constitutional jaundice, etc., who are deemed unsuitable for this clinical trial by the investigating physician. - Part B: Individuals who have a history of or underlying medical conditions such as cardiovascular disease, liver disease, kidney disease, endocrine disease, digestive system disease, hematological disease, respiratory disease, central nervous system disease (including seizure-related disorders (e.g., Parkinson disease), epilepsy, essential tremor, and writer's cramp), skin disease, or constitutional jaundice, whose disease symptoms are unstable (meaning there has been a change in treatment, such as the type or dosage of medication, within 90 days prior to administration of the investigational drug), or who are taking contraindicated medications (substrates of CYP2B6 and CYP3A4/5, strong and moderate inhibitors of CYP3A4/5, or strong inducers of CYP3A4), and who the investigating physician deems unsuitable for this clinical trial. 2) Individuals who have a history of coma lasting more than two hours, loss of consciousness, or skull fracture due to traumatic brain injury, or a history of head surgery (such as removal of brain tumors or intracranial hematomas), and who the clinical trial physician deems unsuitable because they may affect pharmaco-EEG measurements. 3) Individuals with a history of or presenting with a disorder that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug/zonisamide [including individuals with clinically significant abnormalities in the liver or kidneys (AST or ALT exceeding twice the upper limit of normal, total bilirubin or serum creatinine exceeding 1.5 times the upper limit of normal), a history of malabsorption, or a history of gastrointestinal surgery that may affect drug absorption or metabolism]. 4) Individuals who showed eosinophilia exceeding the upper limit of normal values during screening or clinical examination on Day -1. 5) Individuals who had clinically significant abnormalities in hematological tests, blood biochemical tests, lipid tests, or urinalysis results at the time of screening or on Day 1. 6) Individuals who have clinically significant abnormalities detected in a 12-lead electrocardiogram and may not be able to complete this clinical trial. 7) Individuals who exhibit any of the following characteristics during a 12-lead electrocardiogram (ECG) test at the time of screening. - Heart rate > 100 bpm or 120 msec - Corrected QT interval (QTcF) using the Fridericia correction method. Male > 450 msec, female > 470 msec (QTcF=QT/RR1/3) - PR interval > 220 msec 8) Individuals who answered "yes" to item 4 or 5 of the "Suicidal ideation" section of the C-SSRS on Day -1. Item 4: Active suicidal ideation - There is some intention to act, but no concrete plan. Item 5: Active suicidal ideation - with a concrete plan and intention to carry it out. 9) Individuals who were hospitalized wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A, Part B, Part F Safety Assessment parameters (Adverse Events, Clinical Laboratory Tests, Vital Signs, 12-Lead Electrocardiogram, Neurological Examination, C-SSRS) Part C Pharmacokinetic Assessment Parameters Part D, Part E Pharmacodynamic Assessment Parameters (EEG), Safety Assessment Parameters (Adverse Events, Clinical Laboratory Tests, Vital Signs, 12-Lead Electrocardiogram, Neurological Examination, C-SSRS), Pharmacokinetic Assessment Parameters | — |
Contacts
Public ContactProduct information center
Sumitomo Pharma Co., Ltd.
Outcome results
None listed