Multiple system atrophy
Conditions
Interventions
<
MSA-01 group>
To receive MSA-01, 900, 1200 and 1500mg once a day from Day 1 to Day 14 daily
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To receive placebo once a day from Day 1 to Day 14 daily
Sponsors
Department of Neurology, The University of Tokyo Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Participants may be included in the study only if they meet all of the following criteria: 1. are Japanese healthy adult males between the age of 20 and 35. Healthy adult are defined as adults who have no disorders requiring treatment as a result of medical history, clinical examination, laboratory test, vital signs (blood pressure in sitting position, pulse rate and armpit temperature), 12-lead ECG, blood test for infection, and urinary drug screening 2. have a body mass index of over 18.5 kg/m2 on screening visit, under 25.0 kg/m2(approximate body weight over 50.0kg) 3. non-smoker or men who have not smoked for over half a year 4. are capable of visiting the all visit and completing the study 5. have given written informed consent and follow study procedures
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they meet any of the following criteria: 1. are persons who have previously received ubiquinone or ubiquinol 2. family history of multiple system atrophy 3. are persons who have clinically significant disease and are not considered healthy by the investigator as a result of clinical examination, vital signs (blood pressure in sitting position, pulse rate and armpit temperature), 12-lead ECG and clinical examination on screening visit or are not suitable for participation judging from medical history 4. have a significant hepatic disease 5. history or presence of gastrointestinal, hepatic or renal disease known to affect absorption, distribution, metabolism and excretion 6. show positive findings on urinary drug screening on screening visit 7. are concurrently plan to be enrolled in other clinical trial or PMS study 8. are persons who are enrolled in other clinical trial of PMS study and have previously received the investigational product in this study within 3 months from the first administration of investigational product 9. history of drug or another allergy or have an idiosyncrasy (except persons with no evidence of hay fever) 10. history of drug or alcohol dependence 11. have an average weekly alcohol intake that exceeds 14 units per week (1 unit = 150 mL of wine; 350 mL of beer; 45 mL of 80-proof distilled spirits) 12. regularly use prescription medication or over-the-counter medication such as vitamins, crude drug, herbal preparations or supplement and are unable to stop within 14 days prior to administration of investigational product 13. are not willing to or unable to follow study procedures 14. are withdrawn over 400 mL within 4 months or withdrawn over 200 mL within a months from the first administration of investigational product 15. are considered inadequate to perform a lumbar puncture by the investigator 16. are considered inadequate to participate in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)plasma concentration and pharmacokinetic parameters of MSA-01: Cmax, AUC0-t, AUC0-inf(if applicable), tmax, t1/2, Lamda-z, CL/F, Vz/F and MRT(if applicable) 2)safety: clinical examination, vital signs, body weight, laboratory tests, 12-lead ECG, the relationship between drug concentration and QT/QTc interval, and adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)plasma concentration of ubiquinone 2)drug concentration of MSA-01 and ubiquinone in leucocytes and cerebrospinal fluid | — |
Countries
Japan
Contacts
Public ContactToshio Ga
The University of Tokyo Hospital Unit for Early and Exploratory Clinical Development
Outcome results
None listed