Benign Adult Familial Myoclonic Epilepsy (BAFME)
Conditions
Interventions
Part A: DSP-0378 90 mg, 135 mg, 180 mg, 240 mg, 300 mg
Part B: DSP-0378 180 mg, Rifampicin 600 mg
Part C: DSP-0378 90 mg, Itraconazole 200 mg
Sponsors
Tsukada Hironobu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only those who meet all of the following criteria will be considered for inclusion in the clinical trial. 1) Individuals aged 18 to under 50 years old on the date of consent. 2) Healthy adult males or females (Part A), healthy adult males (Part B and Part C). 3) Individuals who, at the time of screening, weigh between 50.0 kg and 85.0 kg and have a Body Mass Index (BMI) of 18 kg/m2 or more but less than 25 kg/m2 (males) or 17.5 kg/m2 or more but less than 25 kg/m2 (females). "BMI = Weight (kg) / [Height (m)]^2" 4) Male participants - Men with a fertile partner must intend to practice daily sexual abstinence or use highly effective contraception from the time of consent until at least 30 days after the end of the study intervention. Female participants - Individuals who are not capable of becoming pregnant (e.g., surgically infertile, postmenopausal). Menopause is defined as the absence of menstruation for 12 months without other medical causes. OR - For women of childbearing age, a negative urinary human chorionic gonadotropin pregnancy test at screening, and the willingness to maintain daily sexual abstinence or use highly effective contraception from the time of informed consent until at least 30 days after the end of the study intervention. 5) The ability to sign the Informed Consent Form (ICF), including compliance with the requirements and restrictions described in the ICF and this clinical trial protocol. 6) The ability to abide by the compliance requirements during participation in the clinical trial, undergo prescribed examinations and tests, and report any symptoms. 7) The ability to communicate appropriately with the principal investigator or designated personnel, and to understand Japanese.
Exclusion criteria
Exclusion criteria: 1) Individuals with a history of clinically significant cardiovascular disease, liver disease, kidney disease, endocrine disease, gastrointestinal disease, hematological disease, respiratory disease, neurological disease, or cranial nerve disease, who are deemed unsuitable as participants in this clinical trial by the principal investigator or other relevant personnel. 2) Individuals who have been diagnosed with a mental disorder (including intellectual disability and substance-related disorders). 3) Individuals with a history of tobacco dependence or smokers who smoke more than 20 cigarettes per day on average. 4) Individuals with disorders or a history of disorders that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug, rifampicin (Part B only), or itraconazole (Part C only). [Clinically significant abnormalities in the liver or kidneys. [Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding twice the upper limit of normal.] [Including individuals with total bilirubin or serum creatinine levels exceeding 1.5 times, constitutional jaundice, a history of malabsorption, or a history of gastrointestinal surgery that may affect drug absorption or metabolism] 5) Individuals with a history of drug allergies 6) Individuals with hypersensitivity to any component of the investigational drug, rifampicin (Part B only), or itraconazole (Part C only) 7) Individuals who were hospitalized within 45 days prior to screening (excluding hospitalization for examination) 8) Individuals with a history of substance abuse or drug abuse 9) Individuals who used prescription or over-the-counter drugs within 14 days prior to the start of the study intervention or within 5 times the half-life of the drug (whichever is longer) 10) Individuals who received a vaccine within 7 days prior to screening or within 7 days prior to Day -1 11) Individuals who have previously participated in a clinical trial of DSP-0378 and received DSP-0378. 12) Individuals who participated in other clinical trials, including post-marketing clinical trials, within 90 days prior to screening and received intervention with investigational drugs/investigational devices/therapeutic products or post-marketing clinical trial drugs/post-marketing clinical trial devices/post-marketing clinical trial products. 13) Individuals who showed clinically significant abnormalities in a 12-lead electrocardiogram at screening or on Day -1, or who showed any of the following findings: - Heart rate > 100 bpm or 220 msec - QRS interval > 120 msec - QT interval (QTcF) corrected by Fridericia correction method > 450 msec (male) or > 470 msec (female) 14) Individuals who tested positive in immunological tests at screening. 15) Individuals who showed eosinophilia exceeding the upper limit of normal in clinical tests at screening or on Day -1. 16) Individuals who tested positive in a 12-lead electrocardiogram at screening or on Day -1. Individuals who, in the clinical examinations on Day -1 (hematological tests, blood biochemistry tests, lipid tests, urinalysis), showed clinically significant abnormalities as judged by the principal investigator, etc. 17) Individuals who tested positive in the urinalysis drug test at screening or on Day -1 18) Individuals who tested positive in the breath alcohol test at screening or on Day -1 19) Individuals who answered "yes" to item 4 (active suicidal ideation: some intention to carr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A - Adverse events - Vital signs -Clinical laboratory tests (including hormone tests) - 12-lead electrocardiogram - Neurological examination - Pulse rate and percutaneous arterial oxygen saturation (SpO2) monitoring - C-SSRS - RASS - Bond-Lader Visual Analogue Scale (BL-VAS) - Profile of Mood States 2nd Edition (POMS 2) - 20-item Physician Withdrawal Checklist (PWC-20) Part B Pharmacokinetic parameters of DSP-0378 Part C Pharmacokinetic parameters of DSP-0378 | — |
Contacts
Public ContactProduct information center
Sumitomo Pharma Co., Ltd.
Outcome results
None listed