Parkinson's DiseasePhase 1NCT03830528
A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects
A Phase 1 study testing KW-6356 Low Dose, KW-6356 Middle Dose and KW-6356 High Dose in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- KW-6356 Low Dose, KW-6356 Middle Dose and KW-6356 High Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- 26 Feb 2019to 10 Oct 2019
- 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 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals who provided freely-given written consent for participating in this study
- Men aged 20 ≥ and < 45 at the time of informed consent;
- Japanese individuals without mixed marriage for at least last two generations, for participating Part A and Part B
- Japanese and Caucasian individuals without mixed marriage for at least last two generations, for participating Part C
- Individuals with BMI ≥ 18.5 and < 30.0
- Individuals with screening results of; resting pulse rate: 40 to 100 bpm, systolic blood pressure: 91 to 140 mmHg, diastolic blood pressure: 40 to 90 mmHg
Who cannot join
- Individuals with any current diseases requiring treatment
- Individuals with current cerebrovascular, gastrointestinal, cardiovascular, hematologic, renal, or liver diseases
- Individuals with current symptomatic allergy
- Individuals with current or past drug allergy
- Individuals with current or past psychiatric disorders
- Individuals with a history of any autoimmune diseases or malignant tumor
Show all 18Show fewer
- Individuals with alcohol or drug dependence, or those who showed any positive result(s) in drug abuse tests
- Individuals with a history of congestive heart failure, hypokalemia, hypocalcemia, or QT prolongation syndrome
- Individuals with positive result in any of viral infection tests (HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen and antibody, and HTLV-1 antibody) or syphilis tests (RPR and TP antibody) at screening.
- Individuals with abnormality in standard 12-lead ECG that the investigator or subinvestigator determined as clinically significant at screening, Day -1, and before administration of the study drug on Day 1.
- Individuals who participated in clinical trial(s) of any medical products and received administration of those within 4 months prior to the study drug administration in the current study
- Individuals who used drugs (including non-prescription drugs, external preparation, vitamins, health supplements, and herbal medicines) within 2 weeks prior to the study drug administration
- Individuals who consumed grapefruit, or any food and beverage containing grapefruit or St John's Wort within 1 week prior to the study drug administration
- Individuals who smoked or used stop-smoking aid products (including chewing or eating nicotine-containing products, or application of nicotine patches) within 4 weeks prior to the study drug administration
- Individuals who admitted to the hospital or had surgery within 3 months prior to the study drug administration
- Individuals who had any of the following blood drawing for donation, clinical trial, or any other reasons prior to the study drug administration; ≥ 400 mL blood collection within 3 months; ≥ 200 mL blood collection within 4 weeks; or blood collection for pheresis (such as plasmapheresis or plateletpheresis) donation, clinical trial, or any other reasons within 2 weeks
- Individuals who did not agree to use appropriate contraceptive measures from the day of admission to 12 weeks after the last administration of study drug. The appropriate contraceptive measures are defined as refraining from sexual activity or combining two contraceptive methods including condom, oral contraceptives, intrauterine contraceptive devices or pessary.
- Any other individuals who were determined as not suitable for participating in this study by the investigator or subinvestigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of KW-6356 in Japanese and Caucasian Healthy Adults
Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers
Read the detailed description
The study will have 3 parts:
- In Part A and Part B, a placebo-controlled double-blind study will be conducted to investigate safety, tolerability and pharmacokinetics of a single dose and 14 days multiple doses of KW-6356 in Japanese healthy men, respectively
- In Part C, an open-label study will be conducted to investigate safety, tolerability and pharmacokinetics of 7 days multiple doses of KW-6356 in Japanese and Caucasian healthy men
- Conditions
- Parkinson's Disease
- Being tested
- KW-6356 Low Dose, KW-6356 Middle Dose, KW-6356 High Dose, KW-6356 X Dose, KW-6356 Y Dose
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-6356 Low DoseDrug
KW-6356 will be administered as single doses.
KW-6356 Middle DoseDrug
KW-6356 will be administered as single doses.
KW-6356 High DoseDrug
KW-6356 will be administered as single doses.
KW-6356 X DoseDrug
KW-6356 will be administered as multiple doses.
KW-6356 Y DoseDrug
KW-6356 will be administered for Japanese healthy men as multiple doses.
PlaceboDrug
All study cohorts (except Part C) are placebo controlled.
| Study group | Role | What they receive |
|---|---|---|
| Part A-1 | Experimental | There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo. Receives: Drug: KW-6356 Low Dose |
| Part A-2 | Experimental | There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo. Receives: Drug: KW-6356 Middle Dose |
| Part A-3 | Experimental | There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo. Receives: Drug: KW-6356 High Dose |
| Part B | Experimental | There will be one cohort of Japanese healthy men dosed with multiple doses of KW-6356 or placebo and one potential additional cohort (KW-6356 dose as determined in Part A or placebo) Receives: Drug: KW-6356 X Dose |
| Part C-1 | Experimental | There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies) Receives: Drug: KW-6356 Y Dose |
| Part C-2 | Experimental | There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies) Receives: Drug: KW-6356 Y Dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A Number and percentage of subjects with treatment-emergent adverse events
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part B Number and percentage of subjects with treatment-emergent adverse events
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part C Profiles of pharmacokinetics of plasma KW-6356 concentrations
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Secondary outcomes (3)
Part A Profiles of pharmacokinetics of plasma KW-6356 concentrations
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part B Profiles of pharmacokinetics of plasma KW-6356 concentrations
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part C Number and percentage of subjects with treatment-emergent adverse events
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start26 Feb 2019
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830528
- Sponsor's protocol ID
- 6356-004
- Status last verified
- Nov 2019
- First submitted
- 3 Feb 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tayama T, Ishiuchi M, Sugiyama K, Oka Y, Maeda H, Nagata Y, Hruska M, Kagawa Y. Safety, Tolerability, and Pharmacokinetics of the Novel Adenosine A2A Antagonist/Inverse Agonist KW-6356 Following Single and Multiple Oral Administration in Healthy Volunteers. Clin Pharmacol Drug Dev. 2023 Aug;12(8):801-809. doi: 10.1002/cpdd.1222. Epub 2023 Jan 22.
PubMed 36683291
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of KW-6356 in Japanese and Caucasian Healthy Adults
- ClinicalTrials.gov ID
- NCT03830528
- Acronym / sponsor ID
- 6356-004
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 5 Feb 2019 (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.
Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers
Detailed description
The study will have 3 parts:
- In Part A and Part B, a placebo-controlled double-blind study will be conducted to investigate safety, tolerability and pharmacokinetics of a single dose and 14 days multiple doses of KW-6356 in Japanese healthy men, respectively
- In Part C, an open-label study will be conducted to investigate safety, tolerability and pharmacokinetics of 7 days multiple doses of KW-6356 in Japanese and Caucasian healthy men
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A-1 | Experimental | Drug: KW-6356 Low DoseThere will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo. |
| Part A-2 | Experimental | Drug: KW-6356 Middle DoseThere will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo. |
| Part A-3 | Experimental | Drug: KW-6356 High DoseThere will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo. |
| Part B | Experimental | Drug: KW-6356 X DoseThere will be one cohort of Japanese healthy men dosed with multiple doses of KW-6356 or placebo and one potential additional cohort (KW-6356 dose as determined in Part A or placebo) |
| Part C-1 | Experimental | Drug: KW-6356 Y DoseThere will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies) |
| Part C-2 | Experimental | Drug: KW-6356 Y DoseThere will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Individuals who provided freely-given written consent for participating in this study
- Men aged 20 ≥ and < 45 at the time of informed consent;
- Individuals with BMI ≥ 18.5 and < 30.0
- Individuals with screening results of; resting pulse rate: 40 to 100 bpm, systolic blood pressure: 91 to 140 mmHg, diastolic blood pressure: 40 to 90 mmHg
Key exclusion criteria (18 listed)
- Individuals with any current diseases requiring treatment
- Individuals with current cerebrovascular, gastrointestinal, cardiovascular, hematologic, renal, or liver diseases
- Individuals with current symptomatic allergy
- Individuals with current or past drug allergy
- Individuals with current or past psychiatric disorders
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 |
|---|---|---|
| KW-6356 Low DoseKW-6356 will be administered as single doses. | Drug | Part A-1 |
| KW-6356 Middle DoseKW-6356 will be administered as single doses. | Drug | Part A-2 |
| KW-6356 High DoseKW-6356 will be administered as single doses. | Drug | Part A-3 |
| KW-6356 X DoseKW-6356 will be administered as multiple doses. | Drug | Part B |
| KW-6356 Y DoseKW-6356 will be administered for Japanese healthy men as multiple doses. | Drug | Part C-1, Part C-2 |
| PlaceboAll study cohorts (except Part C) are placebo controlled. | Drug | Placebo |
Primary outcome
Part A Number and percentage of subjects with treatment-emergent adverse events
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part B Number and percentage of subjects with treatment-emergent adverse events
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part C Profiles of pharmacokinetics of plasma KW-6356 concentrations
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
3 secondary outcomes
Part A Profiles of pharmacokinetics of plasma KW-6356 concentrations
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part B Profiles of pharmacokinetics of plasma KW-6356 concentrations
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part C Number and percentage of subjects with treatment-emergent adverse events
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
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 29 Nov 2019.
- Derived from this study: PubMed 36683291Tayama T, Ishiuchi M, Sugiyama K, Oka Y, Maeda H, Nagata Y, Hruska M, Kagawa Y. Safety, Tolerability, and Pharmacokinetics of the Novel Adenosine A2A Antagonist/Inverse Agonist KW-6356 Following Single and Multiple Oral Administration in Healthy Volunteers. Clin Pharmacol Drug Dev. 2023 Aug;12(8):801-809. doi: 10.1002/cpdd.1222. Epub 2023 Jan 22.
- Individual participant dataSharing planned: Undecided
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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 KW-6356 Low Dose, KW-6356 Middle Dose and KW-6356 High Dose in people with Parkinson's Disease, run by Kyowa Kirin 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 18 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 29 Nov 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?
Part A Number and percentage of subjects with treatment-emergent adverse events (time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose). 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?
On the ClinicalTrials.gov record for NCT03830528, which also lists 1 linked publication.
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 29 Nov 2019.