Clinical Pharmacology Study of KC-8025 in Japanese and Caucasian healthy adults (Phase I).

JRCT ID: jRCT2071230101

Registered date:15/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Japanese and Caucasian healthy adult participants
• Date of first enrollment: 15/12/2023
• Target sample size: 48
• Study type: Interventional
• Intervention(s): Administer repeated oral doses of KC-8025 once a day for seven days in approximately 200mL of water under fasting for at least 10 hours at the prescribed dose.

Outcome(s)

• Primary Outcome: Pharmacokinetics and Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 50age old
• Gender: Both

Include criteria

1. Japanese or Caucasian subjects who are between 18 and 50 years at the time of consent.
2. Weight between 45.0 and 100.0 kg at screening.
3. BMI at screening is more than 18.0 kg/m2 and less than 30.0 kg/m2.

Exclude criteria

1. Subjects with central nervous system disease, heart disease, disorders of the cardiovascular system, respiratory system, blood/hematopoietic system, gastrointestinal system, kidney/liver function, thyroid function, pituitary function, or adrenal function or a history of these diseases/disorders and for whom the conduct of the clinical trial can cause issues with ensuring safety as judged by the investigator.
2. Subjects assessed to be poor metabolizers as per CYP2C9 gene polymorphism tests
3. Subjects with a history of surgery or medical condition that, in the opinion of the investigator, may affect the pharmacokinetics.
4. Subjects who have used medications within 14 days before starting to take the investigational product or who may need to use medications.
5. Subjects who have undergone or are expected to need to undergo treatment at a hospital within 14 days before starting to take the investigational product.
6. Subjects who consumed furanocoumarin-rich citrus fruits (such as grapefruit, pomelo, and Seville oranges) or foods and beverages containing these within 72 hours before starting to take the investigational product.
7. Subjects who regularly consume excessive amounts of alcohol (approximate guide: at least 1.3 L of beer, at least 360 mL of Japanese sake on average per day).
8. Subjects who regularly consume more than 6 servings (1 serving: 150 mL) of coffee, black tea, green tea, cola, or other caffeine-containing beverages per day.
9. Subjects who are habitual smokers (approximate guide: >10 cigarettes per day or equivalent).
10. who undergo blood sampling (such as giving blood) of at least 400 mL within 12 weeks (84 days) before starting to take the investigational product (or within 16 weeks [112 days] before starting for females), blood sampling (such as giving blood) of at least 200 mL within 4 weeks (28 days) before starting to take the investigational product, donate blood components within 2 weeks (14 days) before starting to take the investigational product, or those for whom the total blood volume collected per year including the planned amount of blood sampling for this clinical trial exceeds 1200 mL (or 800 mL for females).
11. Subjects who used other investigational products within 16 weeks (112 days) before starting to take the investigational product (for investigational products with approved ingredients, within 12 weeks [84 days] before starting to take the investigational product).
12. Subjects with (or who had) allergies to medications or other specific constitutions (such as alcohol sensitivity).
13. Subjects with or who previously experienced drug dependence (such as narcotics, stimulants, and psychotropic drugs) or alcohol dependence.
14. Subjects who tested positive for drugs of abuse in urine at screening.
15. Subjects with clinically significant abnormal electrocardiogram (ECG) findings as judged by the investigator on 12-lead ECGs taken at screening.
16. Subjects with positive results in immunological tests (HIV antigen/antibody, HBs antigen, HCV antibody, syphilis) at screening.
17. Women who are pregnant, nursing, or possibly pregnant, women who wish to become pregnant during the period from the day of informed consent to 90 days after the last dose of the investigational product, or men who wish for their partners to become pregnant during this period. Women of childbearing potential with a positive pregnancy test at screening
18. Subjects with positive SARS-CoV-2 test on the day of hospitalization.
19. Employees of Kaken Pharmaceuticals, Inc., investigators, staff of Study site under the direct supervision of investigators, or staff of CROs involved in this clinical trial.

Related Information

• Primary Sponsor: Yonemura Takuma