A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Midazolam
Caffeine
Rosuvastatin
KW-6356
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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.
Sites / Locations
- Fukuoka Mirai Hospital Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KW-6356/Healthy Japanese adult male subjects
Arm Description
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
Outcomes
Primary Outcome Measures
Geometric mean ratio of the major pharmacokinetic parameter (AUC0-t) of the index substrates in combination with or without KW-6356
Secondary Outcome Measures
Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of the index substrates in combination with or without KW-6356
Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of the index substrates in combination with or without KW-6356
Pharmacokinetic parameters (tmax) of the index substrates
Pharmacokinetic parameters (CL/F) of the index substrates
Pharmacokinetic parameters (Vz/F) of the index substrates
Pharmacokinetic parameters (t1/2) of the index substrates
Plasma concentrations of the index substrates
Plasma concentrations of KW-6356
Incidence of treatment-emergent adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03970798
Brief Title
A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
Official Title
A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KW-6356/Healthy Japanese adult male subjects
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
KW-6356
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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.
Facility Information:
Facility Name
Fukuoka Mirai Hospital Clinical Research Center
City
Fukuoka
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
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