Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03068481 |
Date of registration:
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26/02/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
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Scientific title:
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A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease |
Date of first enrolment:
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February 20, 2017 |
Target sample size:
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36 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03068481 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy volunteer part
- 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:
- Healthy volunteer part
- 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
Age minimum:
20 Years
Age maximum:
74 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: Placebo
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Drug: KDT-3594
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Primary Outcome(s)
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Occurrence of adverse events
[Time Frame: Up to 15 days after last administration]
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Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax
[Time Frame: Up to 336 hours after last administration]
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Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC
[Time Frame: Up to 336 hours after last administration]
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Secondary Outcome(s)
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Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part)
[Time Frame: Up to 336 hours after last administration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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