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

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: KDT-3594; Drug: Placebo

• Registration Number: NCT03068481
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-02-26
• Study First Submitted QC: 2017-02-26
• Study First Posted: 2017-03-01
• Primary Completion: 2018-08-13
• Study Completion: 2018-08-13
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient part -Single dose	KDT-3594	Single oral dose of KDT-3594
Healthy volunteer part -Placebo	Placebo	Multiple oral doses of Placebo
Healthy volunteer part -Multiple dose	KDT-3594	Multiple oral doses of KDT-3594
Healthy volunteer part -Single dose	KDT-3594	Single oral dose of KDT-3594
Patient part -Multiple dose	KDT-3594	Multiple oral doses of KDT-3594

Primary Outcome Measures

Name	Time	Method
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
Occurrence of adverse events	Up to 15 days after last administration

Secondary Outcome Measures

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