Parkinson's DiseasePhase 1NCT04070495
A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin
A Phase 1 study testing KW-6356, Clarithromycin and Rifampicin 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 investigate the effects of CYP3A4/5 inhibitor or inducer on the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to healthy Japanese men for 7 days. 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, Clarithromycin and Rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- 27 Aug 2019to 19 Nov 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
- Subjects having issued written consent to this study at their own discretion
- Japanese men aged 20 to 44 years at the time of informed consent
- Subjects with BMI ≥18.5 and <25.0 at screening
- Subjects with screening results of; resting pulse rate: 40 to 100 bpm, systolic blood pressure: 90 to 139 mmHg, diastolic blood pressure: 40 to 89 mmHg
Who cannot join
- Subjects with any current disease requiring treatment
- Subjects having drug allergy or its history
- Subjects 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, or Treponema pallidum (TP) antibody.
- Subjects with clinically significant abnormality detected on 12-lead electrocardiogram (ECG) recorded prior to the first administration of investigational product.
- Subjects categorized as patients listed in the warnings or contraindications section of the package insert of the perpetrator drug.
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- Subjects 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 administration of investigational product.
- Subjects 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 administration of investigational product.
- Subjects 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 administration of investigational product.
- Subjects having received inpatient treatment or surgery within 12 weeks prior to the first administration of investigational product.
- Subjects 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 4 months prior to the first administration of investigational product.
- Subjects having undergone ≥400 mL of blood collection within 12 weeks prior to the first administration of investigational product or ≥200 mL of blood collection within 4 weeks prior to the first administration of investigational product (for blood donation or clinical trial, etc.) or pheresis donation (plateletpheresis or plasmapheresis donation) within 2 weeks prior to the first administration of investigational product.
- Subjects having issued no consent to adoption of any appropriate contraceptive method during the period from day of admission to 12 weeks after the final administration of the perpetrator 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.
- Subjects having received KW-6356 before.
- Other subjects 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
Official title: A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin (A Drug Interaction Study With a CYP3A4/5 Inhibitor or Inducer)
The purpose of this study is to investigate the effects of CYP3A4/5 inhibitor or inducer on the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to healthy Japanese men for 7 days.
- Conditions
- Parkinson's Disease
- Being tested
- KW-6356, Clarithromycin, Rifampicin
- 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-6356Drug
A single oral dose will be administered at Day 1 and 15
ClarithromycinDrug
400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28
RifampicinDrug
600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin | Experimental | Not described Receives: Drug: KW-6356; Drug: Clarithromycin |
| Rifampicin | Experimental | Not described Receives: Drug: KW-6356; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean ratio of the pharmacokinetic parameter (AUC0-t) of KW-6356 in combination with or without a perpetrator drug
Measured: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Secondary outcomes (8)
Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of KW-6356 in combination with or without a perpetrator drug
Measured: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of KW-6356 in combination with or without a perpetrator drug
Measured: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (tmax) of KW-6356
Measured: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (CL/F) of KW-6356
Measured: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (Vz/F) of KW-6356
Measured: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (t1/2) of KW-6356
Measured: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Plasma concentrations of a perpetrator drug
Measured: Starting just before intake of a perpetrator drug at Day 8 and continued until 12 or 24 hours after the last dose of a perpetrator drug.
Incidence of treatment-emergent adverse events
Measured: Starting 24 hours before intake of KW-6356 and continued until 14 days after the last dose of a perpetrator drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start27 Aug 2019
- Primary completion19 Nov 2019
- Study completion19 Nov 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT04070495
- Sponsor's protocol ID
- 6356-008
- Status last verified
- Nov 2019
- First submitted
- 26 Aug 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 and Clarithromycin or Rifampicin (A Drug Interaction Study With a CYP3A4/5 Inhibitor or Inducer)
- ClinicalTrials.gov ID
- NCT04070495
- Acronym / sponsor ID
- 6356-008
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 28 Aug 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 investigate the effects of CYP3A4/5 inhibitor or inducer on the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to healthy Japanese men for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin | Experimental | Drug: KW-6356, Drug: Clarithromycin |
| Rifampicin | Experimental | Drug: KW-6356, Drug: Rifampicin |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects having issued written consent to this study at their own discretion
- Japanese men aged 20 to 44 years at the time of informed consent
- Subjects with BMI ≥18.5 and <25.0 at screening
- Subjects with screening results of; resting pulse rate: 40 to 100 bpm, systolic blood pressure: 90 to 139 mmHg, diastolic blood pressure: 40 to 89 mmHg
Key exclusion criteria (15 listed)
- Subjects with any current disease requiring treatment
- Subjects having drug allergy or its history
- Subjects 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, or Treponema pallidum (TP) antibody.
- Subjects with clinically significant abnormality detected on 12-lead electrocardiogram (ECG) recorded prior to the first administration of investigational product.
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-6356A single oral dose will be administered at Day 1 and 15 | Drug | Clarithromycin, Rifampicin |
| Clarithromycin400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28 | Drug | Clarithromycin |
| Rifampicin600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21 | Drug | Rifampicin |
Primary outcome
Geometric mean ratio of the pharmacokinetic parameter (AUC0-t) of KW-6356 in combination with or without a perpetrator drug
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
8 secondary outcomes
Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of KW-6356 in combination with or without a perpetrator drug
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of KW-6356 in combination with or without a perpetrator drug
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (tmax) of KW-6356
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (CL/F) of KW-6356
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (Vz/F) of KW-6356
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (t1/2) of KW-6356
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Plasma concentrations of a perpetrator drug
Time frame: Starting just before intake of a perpetrator drug at Day 8 and continued until 12 or 24 hours after the last dose of a perpetrator drug.
Incidence of treatment-emergent adverse events
Time frame: Starting 24 hours before intake of KW-6356 and continued until 14 days after the last dose of a perpetrator drug.
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 KW-6356, Clarithromycin and Rifampicin 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 pharmacokinetic parameter (AUC0-t) of KW-6356 in combination with or without a perpetrator drug (time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake 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.