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A Phase 1 Study of ONO-2160/CD

Phase 1
Conditions
Parkinson's disease
Registration Number
JPRN-jRCT2080222651
Lead Sponsor
ONO PHARMACEUTICAL CO.,LTD.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
34
Inclusion Criteria

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 whose Mini Mental State Examination score >= 24 at screening
Age : 20 to 74 years
Sex : male and female

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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