A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: KW-6356; Drug: Clarithromycin; Drug: Rifampicin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Sumida-ku, Tokyo, Japan
      • Medical Co. LTA Sumida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Subjects having issued written consent to this study at their own discretion
2. Japanese men aged 20 to 44 years at the time of informed consent
3. Subjects with BMI ≥18.5 and <25.0 at screening
4. 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:

1. Subjects with any current disease requiring treatment
2. Subjects having drug allergy or its history
3. Subjects 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, or Treponema pallidum (TP) antibody.
5. Subjects with clinically significant abnormality detected on 12-lead electrocardiogram (ECG) recorded prior to the first administration of investigational product.
6. Subjects categorized as patients listed in the warnings or contraindications section of the package insert of the perpetrator drug.
7. 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.
8. 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.
9. 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.
10. Subjects having received inpatient treatment or surgery within 12 weeks prior to the first administration of investigational product.
11. 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.
12. 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.
13. 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.
14. Subjects having received KW-6356 before.
15. Other subjects unsuitable for participating in the study in the opinion of the investigator or subinvestigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clarithromycin	Drug: KW-6356; A single oral dose will be administered at Day 1 and 15; Drug: Clarithromycin; 400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28
Experimental: Rifampicin	Drug: KW-6356; A single oral dose will be administered at Day 1 and 15; Drug: Rifampicin; 600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Geometric mean ratio of the pharmacokinetic parameter (AUC0-t) of KW-6356 in combination with or without a perpetrator drug	Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of KW-6356 in combination with or without a perpetrator drug	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	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	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	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	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	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	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	Starting 24 hours before intake of KW-6356 and continued until 14 days after the last dose of a perpetrator drug.

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Actual): November 19, 2019
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Protein Synthesis Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin; Clarithromycin
• Other Study ID Numbers: 6356-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No