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CompletedNCT04070495Updated Nov 29, 2019

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

A Phase 1 interventional study of KW-6356 and Clarithromycin in Parkinson's Disease, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-29.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
20 Years to 44 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.

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Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Clarithromycin

    Drug: KW-6356 · Drug: Clarithromycin

  • Experimental
    Rifampicin

    Drug: KW-6356 · Drug: Rifampicin

Interventions

  • DrugKW-6356

    A single oral dose will be administered at Day 1 and 15

  • DrugClarithromycin

    400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28

  • DrugRifampicin

    600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

07

Study locations

1 site
  • Medical Co. LTA Sumida Hospital
    Sumida-ku, Tokyo, Japan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04070495
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Aug 28, 2019
Start date
Aug 27, 2019
Primary completion
Nov 19, 2019
Completion
Nov 19, 2019
Last update
Nov 29, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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