Chronic fibrosing interstitial lung diseases with a progressive phenotype
Conditions
Interventions
Orally administer 40 mL of the liquid containing [14C] TAS-115(approx. 1MBq) and TAS-115 100 mg on day 1.
Sponsors
Huang Jinhong
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: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Concentrations of total radioactivity in blood and plasma, plasma TAS-115 and the metabolites concentrations and the pharmacokinetics parameters of TAS-115 and the metabolites - Radioactivity excretion and excretion rate, cumulative excretion, cumulative excretion rate into urine and feces. - Radioactivity excretion and excretion rate, cumulative excretion, cumulative excretion rate in all excreta (urine and feces). - Plasma, urinary, and fecal metabolite profiles of TAS-115 , and structural estimation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of adverse events and treatment-related adverse events - Changes in laboratory test values - Electrocardiogram | — |
Contacts
Public ContactKeita Watanabe
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed