Mass Balance Study of KP-001 in Healthy Adult Males (Phase I)

JRCT ID: jRCT2071230093

Registered date:22/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult male
• Date of first enrollment: 22/11/2023
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Administer a single oral dose of KP-001 containing 14C-KP-001 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: < 55age old
• Gender: Male

Include criteria

1. Japanese males whose age is 18 or over and less than 55 years at the time of consent.
2. Weight at screening is 50.0 kg or over.
3. BMI at screening is more than 18.0 and less than 25.0

Exclude criteria

1. Subjects with central nervous system disease, cardiac disease, circulatory system, respiratory system, blood/hematopoietic system, gastrointestinal system, liver/renal system, thyroid gland function, pituitary gland function, adrenal gland function, or other disorders or pre-existing conditions for which the investigator has determined that conducting the study would raise safety concerns for the subject.
2. Subjects with diabetes mellitus (type I or II) or diseases with abnormal glucose metabolism (glycogen storage disease, hypergalactosemia, primary lactose intolerance, etc.) or with a history of such diseases, and for whom the investigator determines that conducting the study would raise safety concerns for the subject.
3. Subjects with a history of surgical procedures or medical conditions that the investigator considers having the potential to affect the pharmacokinetics of the investigational drug.
4. Subjects who have used or will need to use a drug* within 14 days prior to the administration of the investigational drug.
* Includes supplements, vitamins, nutritional drinks and vaccines other than live vaccines. (e.g., influenza vaccine)
5. Subjects who have administered or will need to administer the therapy within 14 days prior to the administration of the investigational drug.
6. Subjects who received a live vaccine within 90 days prior to administration of the investigational drug.
7. Subjects who have consumed citrus fruits (grapefruit, pomelo, dai dai, etc.) or food or beverages containing high levels of furanocoumarins within 72 hours prior to the administration of the investigational drug.
8. Subjects who habitually consume excessive amounts of alcohol. (Guideline: average daily consumption of more than 1.3 L of beer or 360 mL of sake)
9. Subjects who habitually consume more than 6 cups (1 cup: 150 mL) of coffee, black tea, green tea, cola, or other caffeine-containing food or drink per day
10. Subjects who have an excessive smoking habit (Guideline: more than 10 cigarettes per day) or who do not agree with the instructions to stop smoking during the study period.
11. Subjects who had a blood collection of 400 mL or more (blood donation, etc.) within 12 weeks (84 days) prior to administration of the investigational drug, a blood collection of 200 mL or more (blood donation, etc.) within 4 weeks (28 days) prior to administration of the investigational drug, or a component blood donation within 2 weeks (14 days), or a total annual blood volume exceeding 1200 mL including planned blood collection for this clinical trial.
12. Subjects who received another investigational drug within 16 weeks (112 days) prior to the administration of the investigational drug.
13. Subjects with a history of allergy to drugs (including components of the investigational drug) or other special physical condition. (e.g., alcohol hypersensitivity)
14. Subjects with drug dependence (narcotics, stimulants, psychotropic drugs, etc.) or alcohol dependence or those with a history of such dependence.
15. Subjects who test positive for drugs of abuse in urine at screening.
16. Subjects whose 12-lead ECG at screening is judged by the investigator to have a clinically significant ECG abnormality.
17. Subjects with positive immunological tests (HBs antigen, HBc antibody, HCV antibody, HIV antigen/antibody and syphilis) at screening.
18. Subjects with a positive SARS-CoV-2 test.
19. Subjects who have previously participated in a clinical trial of KP 001 and received the investigational drug.
20. Subjects with occupational exposure to radiation (e.g., workers who handle nuclear or radioactive materials) within 1 year prior to administration of the investigational drug.
21. Subjects who have been administered a radioisotope-labeled substance or exposed to a large dose of radiation (e.g., continuous X-rays, CT scan, gastric barium and PET scans)* within 1 year prior to administration of the investigational drug.
* Examinations with small amounts of radiation exposure (e.g., chest, bone, and dental X-rays, airplane boarding X-rays, etc.) are not applicable.
22. Subjects who have had one or more days of spontaneous defecation (defecation that occurs without laxatives, enema, or evacuation) for less than 3 days in the 7 days prior to obtaining consent or within 7 days prior to admission, or who have diarrhea within 7 days prior to admission.
23. 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: Hanada Ryuzo