Japanese healthy adult male volunteers
Conditions
Interventions
Single-dose part: 800 mg SJP-0139 is orally administered. Multiple-dose part: 800 mg SJP-0139 is orally administered twice-daily from Day 1 to Day 13 and once in the morning on Day 14.
Sponsors
Senju Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects who were capable of giving informed consent at the time of providing consent 2. Japanese healthy male adult volunteers aged between 20 to 55 (at the time of consent) who provided the written informed consent 3. Subjects who are able and willing to adhere the study instructions to the subjects defined in the protocol and the study schedule
Exclusion criteria
Exclusion criteria: 1. Subjects with disease, medical history, physical findings, or laboratory abnormalities affecting evaluation of the study 2. Subjects with a medical history of allergies to drugs or food 3. Subjects with a Body mass index of less than 18.5 or exceeding 25.0 or with a weight of less than 50 kg 4. Subject who had underwent surgery known to affect gastrointestinal absorption of the drug (other than appendectomy and herniation) 5. Subjects with previous medical history or current signs of heart disease 6. Subjects who had participated in other clinical studies and had been dosed with other study drugs within 84 days preceding providing consent 7. Subjects who had used drugs other than the study drug used in this study within 7 days preceding treatment initiation of the study drug 8. Subjects who had taken grapefruit, grapefruit juice, or processed food containing those fruits within 7 days preceding treatment initiation of the study drug 9. Subjects who had taken dietary supplement products containing St. John's Wort within 14 days preceding treatment initiation of the study drug 10. (Only for multiple-dose part) Subjects who had shown any abnormal finding at ophthalmic examinations or who had severe myopia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unchanged SJP-0139 and its metabolites in plasma and pharmacokinetic parameters over 8 days (single-dose) or 21 days (multiple-dose) after the last administration | — |
Countries
Japan
Contacts
Public ContactTakuro Sekiya
Senju Pharmaceutical Co.,Ltd. Clinical Development
Outcome results
None listed