NCT03068481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 parkinson-disease

Timeline
Completed

Started Feb 2017

Typical duration for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

February 26, 2017

Last Update Submit

March 29, 2019

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

  • Occurrence of adverse events

    Up to 15 days after last administration

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

    Up to 336 hours after last administration

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

    Up to 336 hours after last administration

Secondary Outcomes (1)

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

    Up to 336 hours after last administration

Study Arms (5)

Healthy volunteer part -Single dose

EXPERIMENTAL

Single oral dose of KDT-3594

Drug: KDT-3594

Healthy volunteer part -Multiple dose

EXPERIMENTAL

Multiple oral doses of KDT-3594

Drug: KDT-3594

Healthy volunteer part -Placebo

PLACEBO COMPARATOR

Multiple oral doses of Placebo

Drug: Placebo

Patient part -Single dose

EXPERIMENTAL

Single oral dose of KDT-3594

Drug: KDT-3594

Patient part -Multiple dose

EXPERIMENTAL

Multiple oral doses of KDT-3594

Drug: KDT-3594

Interventions

KDT-3594DRUG

Oral administration

Healthy volunteer part -Multiple doseHealthy volunteer part -Single dosePatient part -Multiple dosePatient part -Single dose
PlaceboDRUG

Oral administration

Healthy volunteer part -Placebo

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kyushu and Other Regions, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Healthy volunteer part -Multiple dose: Participant, Healthy volunteer part -Single dose and Patient part: No Masking
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 1, 2017

Study Start

February 20, 2017

Primary Completion

August 13, 2018

Study Completion

August 13, 2018

Last Updated

April 1, 2019

Record last verified: 2019-03

Locations

JP(1)