Parkinson's DiseasePhase 1NCT03970798
A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
A Phase 1 study testing Midazolam, Caffeine and Rosuvastatin in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the influence of repeated oral doses of KW-6356 on the pharmacokinetics of index substrates for CYP3A4/5, CYP1A2 and BCRP. 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?
- Midazolam, Caffeine and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- 22 May 2019to 31 Jul 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 having issued written consent to this study at their own discretion
- Japanese males aged 20 to 44 years at the time of informed consent
- Body mass index (BMI) of 18.5 to <25.0 at screening
- Resting pulse rate of 40 to 100 bpm, systolic blood pressure of 90 to 139 mmHg, and diastolic blood pressure of 40 to 89 mmHg when measured in the supine position at screening
Who cannot join
- Individuals with any current disease requiring treatment
- Individuals having drug allergy or its history
- Individuals having psychiatric disease or its history
- Positive results for any of the following infection-related items examined at screening: hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, human T-lymphotropic virus (HTLV)-1 antibody, rapid plasma reagin (PRP) test, Treponema pallidum (TP) antibody.
- Individuals with clinically significant abnormality detected on 12-lead electrocardiogram (ECG) recorded prior to the first dose of index substrate.
- Individuals categorized as patients listed in the warnings or contraindications section of the package insert of any of the relevant index substrates (see separate protocol annex 6-8)
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- Individuals having used any drug (including over-the-counter [OTC] drugs, topical agents, vitamin preparations, health supplements, and Chinese herbal medicines) within 2 weeks prior to the first dose of index substrate.
- Individuals having consumed grapefruit (including any food or beverage containing grapefruit) or any food or beverage containing St John's wort within 1 week prior to the first dose of index substrate.
- Individuals having smoked or used smoking cessation agents (including chewing or eating of nicotine-containing products and application of nicotine patches) within 4 weeks prior to the first dose of index substrate.
- Individuals having received inpatient treatment or surgery within 12 weeks prior to the first dose of index substrate.
- Individuals having participated in a clinical study of a pharmaceutical product or a medical device or any equivalent study and used the investigational product or the unapproved medical device within 16 weeks prior to the first dose of index substrate.
- Individuals having undergone collection of ≥400 mL of blood within 12 weeks prior to the first dose of index substrate or ≥200 mL of blood within 4 weeks prior to the first dose of index substrate (for blood donation or clinical trial, etc.) or pheresis donation (plateletpheresis or plasmapheresis donation) within 2 weeks prior to the first dose of index substrate.
- Individuals having issued no consent to adoption of any appropriate contraceptive method during a period from day of admission to 12 weeks after the final dose of the study drug. The appropriate contraceptive method is defined as sexual abstinence or use of 2 of the following contraceptive devices: condom, oral contraceptives, intrauterine device, and pessary.
- Individuals having received KW-6356 before.
- Other individuals unsuitable for participating in the study in the opinion of the investigator or subinvestigator.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the influence of repeated oral doses of KW-6356 on the pharmacokinetics of index substrates for CYP3A4/5, CYP1A2 and BCRP.
- Conditions
- Parkinson's Disease
- Being tested
- Midazolam, Caffeine, Rosuvastatin, KW-6356
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.
CaffeineDrug
In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.
RosuvastatinDrug
In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.
KW-6356Drug
In Period 2, Day 4-13(except Day11) a single dose of KW-6356 will be administered after breakfast, Day 11 a single dose of KW-6356 will be administered after fasting for at least 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| KW-6356/Healthy Japanese adult male subjects | Experimental | Period 1: intake of the index substrates at Day 1 (Cohort 1: midazolam, Cohort 2: caffeine + rosuvastatin) followed by Period 2: intake of KW-6356 at Day 4-13, intake of the index substrates at Day 11 Receives: Drug: Midazolam; Drug: Caffeine; Drug: Rosuvastatin; Drug: KW-6356 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean ratio of the major pharmacokinetic parameter (AUC0-t) of the index substrates in combination with or without KW-6356
Measured: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Secondary outcomes (9)
Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of the index substrates in combination with or without KW-6356
Measured: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of the index substrates in combination with or without KW-6356
Measured: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (tmax) of the index substrates
Measured: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (CL/F) of the index substrates
Measured: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (Vz/F) of the index substrates
Measured: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (t1/2) of the index substrates
Measured: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Plasma concentrations of the index substrates
Measured: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Plasma concentrations of KW-6356
Measured: Starting around 2 hours before intake of KW-6356 and continued until 24 hours after the last dose of KW-6356
Incidence of treatment-emergent adverse events
Measured: Starting 24 or 48 hours before intake of the index substrates and continued until 8 days after the last dose of KW-6356
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start22 May 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT03970798
- Sponsor's protocol ID
- 6356-005
- Status last verified
- Nov 2019
- First submitted
- 23 May 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
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 Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
- ClinicalTrials.gov ID
- NCT03970798
- Acronym / sponsor ID
- 6356-005
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 May 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 3 Jun 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.
The purpose of this study is to evaluate the influence of repeated oral doses of KW-6356 on the pharmacokinetics of index substrates for CYP3A4/5, CYP1A2 and BCRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KW-6356/Healthy Japanese adult male subjects | Experimental | Drug: Midazolam, Drug: Caffeine, Drug: Rosuvastatin, Drug: KW-6356Period 1: intake of the index substrates at Day 1 (Cohort 1: midazolam, Cohort 2: caffeine + rosuvastatin) followed by Period 2: intake of KW-6356 at Day 4-13, intake of the index substrates at Day 11 |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals having issued written consent to this study at their own discretion
- Japanese males aged 20 to 44 years at the time of informed consent
- Body mass index (BMI) of 18.5 to <25.0 at screening
- Resting pulse rate of 40 to 100 bpm, systolic blood pressure of 90 to 139 mmHg, and diastolic blood pressure of 40 to 89 mmHg when measured in the supine position at screening
Key exclusion criteria (15 listed)
- Individuals with any current disease requiring treatment
- Individuals having drug allergy or its history
- Individuals having psychiatric disease or its history
- Positive results for any of the following infection-related items examined at screening: hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, human T-lymphotropic virus (HTLV)-1 antibody, rapid plasma reagin (PRP) test, Treponema pallidum (TP) antibody.
- Individuals with clinically significant abnormality detected on 12-lead electrocardiogram (ECG) recorded prior to the first dose of index substrate.
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 |
|---|---|---|
| MidazolamIn Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours. | Drug | KW-6356/Healthy Japanese adult male subjects |
| CaffeineIn Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours. | Drug | KW-6356/Healthy Japanese adult male subjects |
| RosuvastatinIn Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours. | Drug | KW-6356/Healthy Japanese adult male subjects |
| KW-6356In Period 2, Day 4-13(except Day11) a single dose of KW-6356 will be administered after breakfast, Day 11 a single dose of KW-6356 will be administered after fasting for at least 10 hours. | Drug | KW-6356/Healthy Japanese adult male subjects |
Primary outcome
Geometric mean ratio of the major pharmacokinetic parameter (AUC0-t) of the index substrates in combination with or without KW-6356
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
9 secondary outcomes
Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of the index substrates in combination with or without KW-6356
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of the index substrates in combination with or without KW-6356
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (tmax) of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (CL/F) of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (Vz/F) of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Pharmacokinetic parameters (t1/2) of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Plasma concentrations of the index substrates
Time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356
Plasma concentrations of KW-6356
Time frame: Starting around 2 hours before intake of KW-6356 and continued until 24 hours after the last dose of KW-6356
Incidence of treatment-emergent adverse events
Time frame: Starting 24 or 48 hours before intake of the index substrates and continued until 8 days after the last dose of KW-6356
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.
- 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 Midazolam, Caffeine and Rosuvastatin 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 4 inclusion and 15 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. 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?
Geometric mean ratio of the major pharmacokinetic parameter (AUC0-t) of the index substrates in combination with or without KW-6356 (time frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356). 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 29 Nov 2019.