Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: KDT-3594
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteer part -Single dose<br>Single oral dose of KDT-3594 | Drug: KDT-3594<br>* Oral administration<br>|
| Experimental: Healthy volunteer part -Multiple dose<br>Multiple oral doses of KDT-3594 | Drug: KDT-3594<br>* Oral administration<br>|
| Placebo Comparator: Healthy volunteer part -Placebo<br>Multiple oral doses of Placebo | Drug: Placebo<br>* Oral administration<br>|
| Experimental: Patient part -Single dose<br>Single oral dose of KDT-3594 | Drug: KDT-3594<br>* Oral administration<br>|
| Experimental: Patient part -Multiple dose<br>Multiple oral doses of KDT-3594 | Drug: KDT-3594<br>* Oral administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part) |  | Up to 336 hours after last administration |