A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
KW-6356
Clarithromycin
Rifampicin
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Medical Co. LTA Sumida Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Clarithromycin
Rifampicin
Arm Description
Outcomes
Primary Outcome Measures
Geometric mean ratio of the pharmacokinetic parameter (AUC0-t) of KW-6356 in combination with or without a perpetrator drug
Secondary Outcome Measures
Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of KW-6356 in combination with or without a perpetrator drug
Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of KW-6356 in combination with or without a perpetrator drug
Pharmacokinetic parameters (tmax) of KW-6356
Pharmacokinetic parameters (CL/F) of KW-6356
Pharmacokinetic parameters (Vz/F) of KW-6356
Pharmacokinetic parameters (t1/2) of KW-6356
Plasma concentrations of a perpetrator drug
Incidence of treatment-emergent adverse events
Full Information
NCT ID
NCT04070495
First Posted
August 26, 2019
Last Updated
November 27, 2019
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04070495
Brief Title
A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin
Official Title
A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin (A Drug Interaction Study With a CYP3A4/5 Inhibitor or Inducer)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
November 19, 2019 (Actual)
Study Completion Date
November 19, 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 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.
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
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clarithromycin
Arm Type
Experimental
Arm Title
Rifampicin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KW-6356
Intervention Description
A single oral dose will be administered at Day 1 and 15
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28
Intervention Type
Drug
Intervention Name(s)
Rifampicin
Intervention Description
600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
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:
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
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Medical Co. LTA Sumida Hospital
City
Sumida-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin
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