Loading clinical trials...

A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin

NCT03970798•Kyowa Kirin Co., Ltd.

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.

Eligibility

Age

20 - 44 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Individuals having issued written consent to this study at their own discretion
•2. Japanese males aged 20 to 44 years at the time of informed consent
•3. Body mass index (BMI) of 18.5 to \<25.0 at screening
•4. 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

•1. Individuals with any current disease requiring treatment
•2. Individuals having drug allergy or its history
•3. Individuals having psychiatric disease or its history
•4. 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.
•5. Individuals with clinically significant abnormality detected on 12-lead electrocardiogram (ECG) recorded prior to the first dose of index substrate.
•6. 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)
•7. 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.
•8. 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.
•9. 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.
•10. Individuals having received inpatient treatment or surgery within 12 weeks prior to the first dose of index substrate.
+5 more criteria

Locations (1)

Fukuoka Mirai Hospital Clinical Research Center

Fukuoka, Japan

Key Dates

Start Date

May 22, 2019

Primary Completion Date

July 31, 2019

Completion Date

July 31, 2019

Last Updated

November 29, 2019

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

Midazolam

DRUG

Caffeine

DRUG

Rosuvastatin

DRUG

KW-6356

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

View study

RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations