Clinical pharmacology study to evaluate the effects of food on TAS-115 in healthy subjects

JRCT ID: jRCT2071240021

Registered date:11/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype
• Date of first enrollment: 05/08/2024
• Target sample size: 32
• Study type: Interventional

Intervention(s)

This study consists of 4 groups.
Group A-D: Orally administer of TAS-115 (Dose 1 or Dose 2) fasting or after meals. After the washout period, orally administer of TAS-115 again by crossover.

Outcome(s)

• Primary Outcome: PK parameters of TAS-115 (Cmax, AUClast, and AUCinf)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

(1) Provided written informed consent
(2) Men aged 18 or older and younger than 40 years at the time of consent
(3) Weigh at least 50.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height {m}]2) ranging from 18.5 to < 25.0 kg/m2
(4) Vital signs obtained in screening tests within the following ranges
a) Systolic blood pressure (in supine position), 90 to 139 mmHg
b) Diastolic blood pressure (in supine position), 40 to 89 mmHg
c) Pulse rate ranging from 40 to 99 beats/min
d) Body temperature (axilla) ranging from 35.0 to 37.4
(5) Judged to be healthy by the investigator based on the examination findings (subjective symptoms and objective findings), blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests (hematology test, biochemistry test, coagulation test, and urinalysis) at the time of screening tests

Exclude criteria

(1) Accompanying diseases considered inappropriate for participation in this study including hepatic diseases, renal diseases, gastrointestinal diseases, cardiovascular diseases, hematologic diseases, respiratory diseases, immunologic or allergic diseases, neurological or psychiatric diseases, metabolic or endocrinological diseases, or malignant tumors, or a history of these diseases
(2) Had current or previous drug abuse (including use of illicit drugs) or alcoholism
(3) History of hypersensitivity to any component of TAS-115
(4) Consumed foods or beverages containing pomegranate, pomelo, or star fruit within 7 days before study drug administration. Excessive consumption of foods or beverages containing cruciferous vegetables (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) within 7 days before study drug administration
(5) Consumed foods or beverages containing grapefruit or bitter orange within 14 days before study drug administration
(6) Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
(7) Consumed foods or beverages containing fruit juices, alcohol, caffeine, and xanthine within 3days before study drug administration

Related Information

• Primary Sponsor: Motoo Yoshiharu