Clinical pharmacology study to evaluate the drug-drug interactions of TAS-115 in healthy subjects

JRCT ID: jRCT2071210113

Registered date:19/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic fibrosing interstitial lung diseases with a progressive phenotype
• Date of first enrollment: 07/03/2022
• Target sample size: 60
• Study type: Interventional

Intervention(s)

This study consists of 4 cohorts.
Cohort 1: TAS-115 will be administrated as single dose on Day 1 and Day 12, and Rifampicin will be administrated as repeated dose from Day 6 to Day 13.
Cohort 2: TAS-115 will be administrated as single dose on Day 1 and Day 9, and Itraconazole will be administrated as repeated dose from Day 6 to Day 11.
Cohort 3: Digoxin and rosuvastatin will be administrated as a single dose on Day 1 and Day 12, and TAS-115 will be administrated as a single dose on Day 7 and Day 12.
Cohort 4: Metformin will be administrated as a single dose on Day 1 and Day 8, and TAS-115 will be administrated as a single dose on Day 3 and Day 8.

Outcome(s)

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

Secondary Outcome

- Incidence and severity of adverse events and treatment-related adverse events
- Changes in vital signs and 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: 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: Jinhong Huang