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A single- and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of KP-910 in healthy adult males and healthy elderly males.

A single- and multiple ascending dose study of KP-910 in healthy adult males and healthy elderly males.

96

Japanese males aged 18 to 54 at the time of consent obtained. For the elderly-targeted step, Japanese males aged 65 or older at the time of consent obtained are targeted.

Subjects with consent obtained: 407 Subjects eligible at screening: 333 Subjects who started study drug treatment: 96 (Part A : 64, Part B: 32) Subjects who completed post-examination: 94 (Part A : 64, Part B: 30)

Adverse events The number of subjects who experienced adverse events was as follows: In Part A, one subject each experienced " Pharyngitis" in the 20 mg group (1/6), "Malaise" in the 50 mg group (1/6), "Abdominal pain" and "Diarrhoea" in the 100 mg group (post-meal) (1/6 each), and "Diarrhoea" in the 200 mg group (1/6). In Part B, one subject each in the placebo group experienced "Extrasystoles," " Hordeolum," " Dizziness," "Headache," and "Epistaxis " (1/8 each). In the 50 mg group, one subject experienced "Diarrhoea" (1/6). In the 100 mg group, one subject each experienced "Contusion " and " Alanine aminotransferase increased " (1/6 each). In the 150 mg group, one subject each experienced " Cheilitis" and " Diarrhoea" (1/6 each). All adverse events were Grade 1 in severity.No adverse event occurred in two or more subjects in any of the dose groups. In the KP-910 groups, no central nervous system or cardiovascular adverse events were observed.

Plasma Drug Concentration: For this study, the pharmacokinetic analysis population consisted of 54 subjects from Part A and 24 subjects from Part B, excluding the placebo group from the safety analysis population. In Part A [2.5 mg to 300 mg groups, 100 mg group (fed), and 50 mg group (elderly)], the pharmacokinetic parameters for KP-910 plasma concentration on Day 1 were as follows: median Tmax was 0.500-2.25 h, mean Cmax was 33.2-1680 ng/mL, mean AUC0-inf was 0.540-62.1 ug*h/mL, and mean T1/2 was 12.2-44.3 h. In Part B (25 mg to 150 mg groups), the pharmacokinetic parameters for KP-910 plasma concentration on Day 10 were as follows: median Tmax was 1.50-2.00 h, mean Cmax was 609-3640 ng/mL, mean AUC0-inf was 5.57-195 ug*h/mL, and mean T1/2 was 37.4-60.6 h. In all dose groups, the plasma concentration of KP-910 was considered to have large individual variability among subjects.

No adverse events occurred in two or more subjects, and no central nervous system or cardiovascular adverse events were observed when KP-910 was administered at the dosage and for the duration specified in this clinical trial

Jan. 12, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071230041

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

July. 14, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Japanese male aged 18 to 55 years old at the time of consent. For the step for elderly subjects, Japanese male aged 65 years or older 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

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. 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.
3. Diagnosed as having the potential to affect pharmacokinetics because of a history of surgical procedures or medical conditions.
4. Subjects who have used or will need to use the drug within 14 days prior to administration of the investigational drug.
5. Subjects who have administered or will need to administer a therapy within 14 days prior to administration of the investigational drug.
6. 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.
7. 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).
8. 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
9. Subjects who are heavy smokers (approximately more than the equivalent of 10 cigarettes per day).
10. 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.
11. Subjects who received another investigational product within 16 weeks (112 days) prior to receiving the investigational product.
12. Subjects who have a history of allergy to any drug or have any other special physical condition (e.g., hypersensitivity to alcohol).
13. Subjects who have drug dependence (narcotics, stimulants, psychotropic drugs, etc.) or alcohol dependence, or those with a history of such dependence.
14. Subjects who test positive for drugs of abuse in urine at screening.
15. Diagnosed with QTcF > 450 msec or clinically significant ECG abnormality on 12-lead electrocardiogram at screening.
16. Subjects with positive immunological tests (HIV antigen/antibody, HBs antigen, HCV antibody, syphilis) at screening
17. Subjects with a positive SARS-Cov2 test on the day of admission
18. 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
19. In the case of elderly subjects, those whose estimated creatinine clearance (Cockcroft-Gault formula) is less than 60 mL/min at screening

Male

Healthy male

Administer a single oral dose of KP-910 or repeated oral doses for 10 days in the fasting state at the prescribed dose

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

+81-92-283-7701

July. 13, 2023

none