Repeated-dose study for oral A4250 in healthy Japanese adult subject

JRCT ID: jRCT2071220050

Registered date:03/09/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Progressive Familial Intrahepatic Cholestasis
• Date of first enrollment: 20/09/2022
• Target sample size: 9
• Study type: Interventional
• Intervention(s): Subjects will receive multiple doses of A4250 3 mg or placebo capsules once daily for 7 days

Outcome(s)

Primary Outcome

Safety: Adverse events, laboratory tests (blood biochemistry, haematology and urinalysis), vital signs (blood pressure and pulse rate), body temperature, standardized 12-lead ECG, and Bowel Habit Diary/Bristol Stool Form Scale 24 hours after administration
PK: PK parameters
PD: Plasma bile acid and bile acid synthetic markers

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

- Japanese healthy male volunteers aged 18 to 45 years at the time of informed consent
- Individuals who weigh 50 kg or more and have a body mass index (BMI) between 18 and 32 kg/m2 (incl) at screening
- Those who are able to communicate well with the investigator or subinvestigator and study staff and comply with the requirements of the entire study
- Individuals who gave written consent to participate in the study prior to the examination or evaluation of the study
- Individuals judged by the investigator (or subinvestigator) to have no health problems at screening based on their medical history, physical findings, vital signs, standard 12-lead ECG, and laboratory test results
- Individuals who agree to contraception using a blocked contraceptive device (condom) and female partner's contraception from the time of informed consent to 90 days after the last dose of the investigational product, and who agree that sperm donation is also prohibited during the same period. The principal investigator or subinvestigator will instruct the female partner on the appropriate contraceptive method and the duration of contraception through the subject.

Exclude criteria

- Individuals with a history of or suffering from clinically significant acute or chronic disease based on the screening interview and physical findings
- Individuals with or without a history of gastrointestinal, hepatic, or renal diseases or other diseases known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Individuals with a history of drug allergy, food allergy, allergic rash, asthma, intolerance to any drug, hypersensitivity or photosensitivity.

Related Information

• Primary Sponsor: Achiwa Hiroyuki