Drug-drug interaction study of TAS-115 with lansoprazole in healthy subjects

JRCT ID: jRCT2071210016

Registered date:28/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Idiopathic pulmonary fibrosis
• Date of first enrollment: 11/07/2021
• Target sample size: 14
• Study type: Interventional

Intervention(s)

Day 1:TAS-115 will be orally administered.
Day11-Day14:Lansoprazole will be orally administered once a day.
Day 15:Lansoprazole will be orally administered and TAS-115 will be orally administered 1 hour later.

Outcome(s)

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

Secondary Outcome

- Incidence of adverse events and treatment-related adverse events
- Changes in laboratory test values
- Electrocardiogram

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

(1) Provided written informed consent
(2) Men aged 20 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 37.0
(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, 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

Related Information

• Primary Sponsor: Huang Jinhong