A Phase 1 Mass Balance Study of Oral [14C] TAS-115 in Healthy Adult Male Subjects

JRCT ID: jRCT2071210058

Registered date:07/09/2021

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: 25/11/2021
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Orally administer 40 mL of the liquid containing [14C] TAS-115(approx. 1MBq) and TAS-115 100 mg on day 1.

Outcome(s)

Primary Outcome

- 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 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