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

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

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There is no data because the clinical trial was terminated before the administration of the investigational product.

No

Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/

https://jrct.mhlw.go.jp/latest-detail/jRCT2071240021

Motoo Yoshiharu

Fukui-ken Saiseikai Hospital

Funabashi 7-1, Wadanaka-cho, Fukui City, Fukui

y-ishibashi@taiho.co.jp

Ishibashi Yuko

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3293-2113

y-ishibashi@taiho.co.jp

Complete

Aug. 05, 2024

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

crossover assignment

treatment purpose

(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

(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

Male

Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype

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.

PK parameters of TAS-115 (Cmax, AUClast, and AUCinf)

+81-92-283-7701

July. 12, 2024

none