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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03068481

Enrollment

Registered

2017-03-01

Start date

2017-02-20

Completion date

2018-08-13

Last updated

2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

DRUGKDT-3594

Oral administration

DRUGPlacebo

Oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Masking description

Healthy volunteer part -Multiple dose: Participant, Healthy volunteer part -Single dose and Patient part: No Masking

Intervention model description

Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part)	Up to 336 hours after last administration

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026