Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
NCT ID: NCT03068481
Last Updated: 2019-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2017-02-20
2018-08-13
Brief Summary
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The purpose of this study in patients with Parkinson's disease is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594. The exploratory efficacy of KDT-3594 will also be investigated.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Healthy volunteer part -Single dose
Single oral dose of KDT-3594
KDT-3594
Oral administration
Healthy volunteer part -Multiple dose
Multiple oral doses of KDT-3594
KDT-3594
Oral administration
Healthy volunteer part -Placebo
Multiple oral doses of Placebo
Placebo
Oral administration
Patient part -Single dose
Single oral dose of KDT-3594
KDT-3594
Oral administration
Patient part -Multiple dose
Multiple oral doses of KDT-3594
KDT-3594
Oral administration
Interventions
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KDT-3594
Oral administration
Placebo
Oral administration
Eligibility Criteria
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Inclusion Criteria
* Healthy Japanese males aged 20 to 35 years, inclusive
* Patient part
* Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
* Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
* Male patients with Parkinson's disease aged 20 to 74 years inclusive, post-menopausal female patients with Parkinson's disease aged 50 to 74 years inclusive
Exclusion Criteria
* Subjects with any abnormal findings in physical examination vital signs, 12-lead ECG, clinical laboratory tests, ophthalmic examinations and electroencephalography
* Patient part
* Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
* Healthy volunteer part and patient part
* Subjects who do not agree to avoid dangerous works such as driving, mechanical operation and high-place work until completion of the follow-up examination
20 Years
74 Years
ALL
Yes
Sponsors
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Kissei Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Kyushu and Other Regions, , Japan
Countries
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Other Identifiers
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KDT1102
Identifier Type: -
Identifier Source: org_study_id
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