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

JRCT ID: jRCT2071230041

Registered date:14/07/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy male
• Date of first enrollment: 04/08/2023
• Target sample size: 96
• Study type: Interventional
• Intervention(s): Administer a single oral dose of KP-910 or repeated oral doses for 10 days in the fasting state at the prescribed dose

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Murakami Harumi