Healthy male subjects
Conditions
Interventions
TRM-1106 65mL x q4h (12dose/44h)
Placebo 65mL x q4h (12dose/44h)
TRM-1106 100mL x q6h (8dose/42h)
Placebo 100mL x q6h (8dose/42h)
Sponsors
Terumo Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Male subject aged at least 20 years (at the date of signing the consent form) 2) Subject who has voluntarily provided written consent prior to enrollment, and is willing to continuously participate in the Study. 3) Subject with a body weight of >=50.0 kg, and a body mass index (BMI) between 18.0 and 35.0. However, subject may participate even if outside this range. In such a case, the investigator or sub-investigator must determine whether it is medically tolerable. 4) Subject without any medically significant abnormality in clinical symptoms or signs (in the results of medical examinations, laboratory tests, and physiological tests) 5) Subject who can take effective contraceptive measures during the study period.
Exclusion criteria
Exclusion criteria: 1) Subject who has been tested positive in a urine drug test or has a history of drug abuse. 2) Subject who has been tested positive for HBs antigen, HCV antibody or HIV antibody, or who has a positive serological test for syphilis. 3) Subject who has a history of hypersensitivity or allergy to the study drug (active component and additives) 4) Subject who currently has or has a history of peptic ulcer; or subject who currently has or has a history of asthma. 5) Subject with clinically significant disease related to the heart, liver, kidneys, respiratory system, gastrointestinal system, endocrine system, immune system, skin, blood, or psychiatric/nervous system. 6) Subject who has liver function test values (T-Bil/D-Bil, ALT (GPT), AST (GOT), gamma-GTP and ALP) that exceed the facility's upper limit. However, if the investigator deems that the reason for exceeding the limit is not due to the liver, the subject may be enrolled. 7) Subject who currently has or have a history of clinically significant bleeding or bleeding tendency. 8) Subject who has taken other medication or supplements within 1 week prior to study drug administration. 9) Subject who need to take other medication concurrently while participating in this study. 10) Subject who smoked tobacco within 1 month prior to study drug administration. 11) Subject who habitually consume a large amount of alcohol (ingestion of >=60 g per day as pure alcohol), or have ingested alcohol within 3 days prior to study drug administration. 12) Subject who has ingested food products containing St. John's wort within 2 weeks prior to study drug administration. 13) Subjects who has ingested grapefruit or processed grapefruit products within 1 week prior to study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of TRM-1106 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan
Contacts
Public ContactSatoshi Yamamoto
Terumo Corporation Clinical Development Department
Outcome results
None listed