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

March 29, 2019 updated by: Kissei Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyushu And Other Regions, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events
Time Frame: Up to 15 days after last administration
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
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
Up to 336 hours after last administration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kissei Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2017

Primary Completion (Actual)

August 13, 2018

Study Completion (Actual)

August 13, 2018

Study Registration Dates

First Submitted

February 26, 2017

First Submitted That Met QC Criteria

February 26, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDT1102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe