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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03970798
• Date of registration: 23/05/2019
• Prospective Registration: No
• Primary sponsor: Kyowa Kirin Co., Ltd.
• Public title: A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
• Scientific title: A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
• Date of first enrolment: May 22, 2019
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03970798
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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.

11. 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.

12. 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.

13. 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.

14. Individuals having received KW-6356 before.

15. Other individuals unsuitable for participating in the study in the opinion of the
investigator or subinvestigator.



Age minimum: 20 Years
Age maximum: 44 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Caffeine

Drug: Midazolam

Drug: Rosuvastatin

Drug: KW-6356

Primary Outcome(s)

Geometric mean ratio of the major pharmacokinetic parameter (AUC0-t) of the index substrates in combination with or without KW-6356 [Time Frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356]

Secondary Outcome(s)

Plasma concentrations of KW-6356 [Time Frame: Starting around 2 hours before intake of KW-6356 and continued until 24 hours after the last dose of KW-6356]

Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of the index substrates in combination with or without KW-6356 [Time Frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356]

Pharmacokinetic parameters (Vz/F) of the index substrates [Time Frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356]

Plasma concentrations of the index substrates [Time Frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356]

Pharmacokinetic parameters (CL/F) of the index substrates [Time Frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356]

Pharmacokinetic parameters (tmax) of the index substrates [Time Frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356]

Incidence of treatment-emergent adverse events [Time Frame: Starting 24 or 48 hours before intake of the index substrates and continued until 8 days after the last dose of KW-6356]

Pharmacokinetic parameters (t1/2) of the index substrates [Time Frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356]

Geometric mean ratio of the major pharmacokinetic parameters (AUC0-8) of the index substrates in combination with or without KW-6356 [Time Frame: Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356]

Secondary ID(s)

6356-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors