Parkinson DiseasePhase 1NCT03068481
Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
A Phase 1 study testing KDT-3594 in people with Parkinson Disease, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- KDT-3594
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 20 Feb 2017to 13 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- KDT-3594, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDT-3594Drug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer part -Single dose | Experimental | Single oral dose of KDT-3594 Receives: Drug: KDT-3594 |
| Healthy volunteer part -Multiple dose | Experimental | Multiple oral doses of KDT-3594 Receives: Drug: KDT-3594 |
| Healthy volunteer part -Placebo | Placebo comparator | Multiple oral doses of Placebo Receives: Drug: Placebo |
| Patient part -Single dose | Experimental | Single oral dose of KDT-3594 Receives: Drug: KDT-3594 |
| Patient part -Multiple dose | Experimental | Multiple oral doses of KDT-3594 Receives: Drug: KDT-3594 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Measured: Up to 15 days after last administration
Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax
Measured: Up to 336 hours after last administration
Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC
Measured: Up to 336 hours after last administration
Secondary outcomes (1)
Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part)
Measured: Up to 336 hours after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start20 Feb 2017
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068481
- Sponsor's protocol ID
- KDT1102
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03068481
- Acronym / sponsor ID
- KDT1102
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer part -Single dose | Experimental | Drug: KDT-3594Single oral dose of KDT-3594 |
| Healthy volunteer part -Multiple dose | Experimental | Drug: KDT-3594Multiple oral doses of KDT-3594 |
| Healthy volunteer part -Placebo | Placebo comparator | Drug: PlaceboMultiple oral doses of Placebo |
| Patient part -Single dose | Experimental | Drug: KDT-3594Single oral dose of KDT-3594 |
| Patient part -Multiple dose | Experimental | Drug: KDT-3594Multiple oral doses of KDT-3594 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteer part
- Patient part
Key exclusion criteria (6 listed)
- Healthy volunteer part
- Patient part
- Healthy volunteer part and patient part
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KDT-3594Oral administration | Drug | Healthy volunteer part -Multiple dose, Healthy volunteer part -Single dose, Patient part -Multiple dose, Patient part -Single dose |
| PlaceboOral administration | Drug | Healthy volunteer part -Placebo |
Primary outcome
Occurrence of adverse events
Time frame: 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
Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC
Time frame: Up to 336 hours after last administration
1 secondary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part)
Time frame: Up to 336 hours after last administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KDT-3594 in people with Parkinson Disease, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (time frame: Up to 15 days after last administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.