Chronic fibrosing interstitial lung diseases with a progressive phenotype
Conditions
Interventions
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-
Sponsors
Jinhong Huang
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters of TAS-115, digoxin, Rosuvastatin, Metformin (Cmax, AUClast, and AUCinf) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence and severity of adverse events and treatment-related adverse events - Changes in vital signs and laboratory test values - Electrocardiogram | — |
Contacts
Public ContactWatanabe Keita
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed