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

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03068481
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 5
• Actual Duration (Months): 17.7
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: KDT-3594; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single GroupHealthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group
• Masking: Single (Participant)
• Masking Description: Healthy volunteer part -Multiple dose: Participant, Healthy volunteer part -Single dose and Patient part: No Masking
• Primary Purpose: Other
• Official Title: A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
• Actual Study Start Date: Feb 20, 2017
• Actual Primary Completion Date: Aug 13, 2018
• Actual Study Completion Date: Aug 13, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Occurrence of adverse events [Up to 15 days after last administration]

2. Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax [Up to 336 hours after last administration]

3. Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC [Up to 336 hours after last administration]

Secondary Outcome Measures

1. Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part) [Up to 336 hours after last administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kyushu And Other Regions		Japan

Sponsors and Collaborators

• Kissei Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kissei Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03068481
• Other Study ID Numbers: KDT1102
• First Posted: Mar 1, 2017
• Last Update Posted: Apr 1, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Apr 1, 2019