臨床研究等提出・公開システム

A study to evaluate the effect of CYP2C19 gene polymorphisms on the safety, tolerability and pharmacokinetics of repeated oral administration of KP-910 in healthy adult males

Clinical pharmacology study of KP-910 in healthy adult males

Murakami Harumi

SOUSEIKAI Sumida Hospital

1-29-1, Honjo, Sumida-ku, Tokyo

harumi-murakami@lta-med.com

Contact for Clinical Trial

Kaken Pharmaceutical Co. Ltd.

2-28-8 Honkomagome, Bunkyo-ku, Tokyo

+81-120-391-004

kaken-jrct@e-medinfo.com

Complete

April. 11, 2025

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

1. Japanese male aged 18 to 55 years old at the time of consent.
2. Male whose weight at screening is 50.0 kg or over.
3. Male whose BMI at screening is between 18.0 and 25.0.
4. Applicants who have consented to the CYP2C19 gene polymorphism test

1. Diagnosed as difficult to participate in the clinical trial because of a problem with ensuring the safety of the subject who has disorders or a history of the central nervous system, heart disease, circulatory system, respiratory system, blood/hematopoietic system, gastrointestinal system, liver/renal system, thyroid function, pituitary function, adrenal function, etc.
2. Those with a history of mental disorders or those with suicidal thoughts as assessed using the C-SSRS (Columbia-suicide severity rating scale)
3. Diagnosed as difficult to participate in the clinical trial because of a problem with ensuring the safety of the subject who has symptoms or a history of dizziness or lightheadedness.
4. Diagnosed as having the potential to affect pharmacokinetics because of a history of surgical procedures or medical conditions.
5. Subjects who have used or will need to use the drug within 14 days prior to administration of the investigational drug.
6. Subjects who have administered or will need to administer a therapy within 14 days prior to administration of the investigational drug.
7. Subjects who have consumed food or drink containing St. John's Wort within 14 days of receiving the investigational drug
8. Subjects who have consumed citrus fruits (grapefruit, pomelo, dai dai, etc.) or foods or beverages containing high levels of furanocoumarins within 72 hours prior to the administration of the investigational drug.
9. Subjects who habitually consume excessive amounts of alcohol (guideline: average daily intake of more than 1.3 L of beer or 360 mL of sake).
10. Subjects who habitually consume more than 6 cups (1 cup: 150 mL) of coffee, black tea, green tea, cola, or other caffeine-containing beverages per day
11. Subjects who are heavy smokers (approximately more than the equivalent of 10 cigarettes per day).
12. Subjects who underwent blood sampling more than 400 mL within 12 weeks (84 days) prior to administration of the investigational drug, blood sampling more than 200 mL within 4 weeks (28 days) prior to administration of the investigational drug, or blood component donation within 2 weeks (14 days) prior to administration of the investigational drug, or whose total annual blood volume exceeds 1200 mL including planned blood sampling volume for this clinical trial.
13. Subjects who received another investigational product within 12 weeks (84 days) prior to receiving the investigational productor within 5 times the half-life of the investigational drug.
14. Subjects who have received KP-910 in the past.
15. Subjects who have a history of allergy to any drug or have any other special physical condition (e.g., hypersensitivity to alcohol).
16. Subjects who have drug dependence (narcotics, stimulants, psychotropic drugs, etc.) or alcohol dependence, or those with a history of such dependence.
17. Subjects who test positive for drugs of abuse in urine at screening.
18. Diagnosed with QTcF > 450 msec or clinically significant ECG abnormality on 12-lead electrocardiogram at screening.
19. Subjects with positive immunological tests (HIV antigen/antibody, HBs antigen, HCV antibody, syphilis) at screening
20. Subjects with a positive SARS-Cov2 test on the day of admission
21. Employees of Kaken Pharmaceutical Co. Ltd., principal (sub) investigator medical institution staff under the direct supervision of the investigators, or CRO staff involved in this study

Male

Healthy male

KP-910 is orally administered at the prescribed dose after breakfast for 14 days .

Pharmacokinetics and Safety (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram, C-SSRS)

+81-92-283-7701

April. 11, 2025

No

none