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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
KDT-3594
Placebo
Sponsored by
Kissei Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Healthy volunteer part -Single dose

Healthy volunteer part -Multiple dose

Healthy volunteer part -Placebo

Patient part -Single dose

Patient part -Multiple dose

Arm Description

Single oral dose of KDT-3594

Multiple oral doses of KDT-3594

Multiple oral doses of Placebo

Single oral dose of KDT-3594

Multiple oral doses of KDT-3594

Outcomes

Primary Outcome Measures

Occurrence of adverse events
Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax
Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part)

Full Information

First Posted
February 26, 2017
Last Updated
March 29, 2019
Sponsor
Kissei Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03068481
Brief Title
Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
Official Title
A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
August 13, 2018 (Actual)
Study Completion Date
August 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group
Masking
Participant
Masking Description
Healthy volunteer part -Multiple dose: Participant, Healthy volunteer part -Single dose and Patient part: No Masking
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteer part -Single dose
Arm Type
Experimental
Arm Description
Single oral dose of KDT-3594
Arm Title
Healthy volunteer part -Multiple dose
Arm Type
Experimental
Arm Description
Multiple oral doses of KDT-3594
Arm Title
Healthy volunteer part -Placebo
Arm Type
Placebo Comparator
Arm Description
Multiple oral doses of Placebo
Arm Title
Patient part -Single dose
Arm Type
Experimental
Arm Description
Single oral dose of KDT-3594
Arm Title
Patient part -Multiple dose
Arm Type
Experimental
Arm Description
Multiple oral doses of KDT-3594
Intervention Type
Drug
Intervention Name(s)
KDT-3594
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Occurrence of adverse events
Time Frame
Up to 15 days after last administration
Title
Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax
Time Frame
Up to 336 hours after last administration
Title
Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC
Time Frame
Up to 336 hours after last administration
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part)
Time Frame
Up to 336 hours after last administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
City
Kyushu And Other Regions
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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