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The purpose of this study in healthy adult males is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteer part -Single dose | Experimental | Single oral dose of KDT-3594 |
|
| Healthy volunteer part -Multiple dose | Experimental | Multiple oral doses of KDT-3594 |
|
| Healthy volunteer part -Placebo | Placebo Comparator | Multiple oral doses of Placebo |
|
| Patient part -Single dose | Experimental | Single oral dose of KDT-3594 |
|
| Patient part -Multiple dose | Experimental | Multiple oral doses of KDT-3594 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KDT-3594 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | Up to 15 days after last administration | |
| Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax | Up to 336 hours after last administration | |
| Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC | Up to 336 hours after last administration |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part) | Up to 336 hours after last administration |
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Inclusion Criteria:
Healthy volunteer part
Patient part
Exclusion Criteria:
Healthy volunteer part
Patient part
Healthy volunteer part and patient part
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu and Other Regions | Japan |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group
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Healthy volunteer part -Multiple dose: Participant, Healthy volunteer part -Single dose and Patient part: No Masking
| Placebo | Drug | Oral administration |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |