A Phase 1 Study of ONO-2160/CD
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCT2080222143
- Lead Sponsor
- ONO PHARMACEUTICAL CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 42
Healthy adult part
1. : BMI >=18.5, <25.0
Age : 20 to 45 years
Sex : male
Parkinson's disease patient part
1. Patients who have been diagnosed with Parkinson's Disease according to the clinical diagnosis criteria of UK Parkinson's Disease Society Brain Bank
2. Patients who have been administered levodopa/carbidopa hydrate combination tablets without prescription change within 28 days in prior to the study drug administration in the Period 1
Age : 20 to 74 years
Sex : male and female
Healthy adult part
1. A volunteer who has developed acute gastrointestinal symptoms (e.g. diarrhea, nausea, heart burn) within 7 days in prior to the study drug administration, or a volunteer who is observed with these gastrointestinal symptoms on a daily basis.
Parkinson's disease patient part
1. A patient whose medical history, physical findings, laboratory test results can suggest parkinsonism from other causes than Parkinson's Disease
2. A patient who has received surgical treatments for Parkinson's Disease such as stereotactic neurosurgery, or who is planned with surgical treatments during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, PK
- Secondary Outcome Measures
Name Time Method