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Completed

NCT Number: NCT03068481

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyushu and Other Regions, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KDT-3594

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. Occurrence of adverse events

    Time frame: Up to 15 days after last administration

  2. Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax

    Time frame: Up to 336 hours after last administration

  3. Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC

    Time frame: Up to 336 hours after last administration

Secondary outcomes

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

    Time frame: Up to 336 hours after last administration

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2017
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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