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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03068481
• Date of registration: 26/02/2017
• Prospective Registration: No
• Primary sponsor: Kissei Pharmaceutical Co., Ltd.
• Public title: Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
• Scientific title: A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
• Date of first enrolment: February 20, 2017
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03068481
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

Japan

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Placebo

Drug: KDT-3594

Primary Outcome(s)

Occurrence of adverse events [Time Frame: Up to 15 days after last administration]

Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax [Time Frame: Up to 336 hours after last administration]

Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC [Time Frame: Up to 336 hours after last administration]

Secondary Outcome(s)

Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part) [Time Frame: Up to 336 hours after last administration]

Secondary ID(s)

KDT1102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors