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

Kissei

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: KDT-3594; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03068481

KDT1102

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 5 patient groups, including a placebo group

Healthy volunteer part -Single dose

Experimental group

Description:

Single oral dose of KDT-3594

Treatment:

Drug: KDT-3594

Healthy volunteer part -Multiple dose

Experimental group

Description:

Multiple oral doses of KDT-3594

Treatment:

Drug: KDT-3594

Healthy volunteer part -Placebo

Placebo Comparator group

Description:

Multiple oral doses of Placebo

Treatment:

Drug: Placebo

Patient part -Single dose

Experimental group

Description:

Single oral dose of KDT-3594

Treatment:

Drug: KDT-3594

Patient part -Multiple dose

Experimental group

Description:

Multiple oral doses of KDT-3594

Treatment:

Drug: KDT-3594