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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

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

20 Years - 44 Years (Adult)MaleAccepts Healthy Volunteers

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

NCT ID

NCT03970798

First Posted

May 23, 2019

Last Updated

November 27, 2019

Sponsor

Kyowa Kirin Co., Ltd.

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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