Healthy volunteers
Conditions
Interventions
A single oral dose of JNT-517 75 mg or 150 mg will be administered under fasting conditions.
Sponsors
Tsunoda Takeshi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese males aged >=18 years and =18.5 kg/m2 and =50 kg at screening. 4) Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the investigator or subinvestigator, to comply with all the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1) Participants with any clinically significant abnormal findings in their medical history or the assessments at screening or admission that, in the investigator's or subinvestigator's opinion, may pose a risk to the participants or affect drug absorption, distribution, metabolism, excretion, or endpoints. This includes, but is not limited to prior or concurrent cardiovascular, hepatic, renal, neurological, endocrine, gastrointestinal, respiratory, hematological, or immunological diseases. 2) Participants who have a prior history or current condition of hepatitis or acquired immunodeficiency syndrome, or who are positive on immunological tests (hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] antibody, human immunodeficiency virus [HIV] antigen/antibody, or syphilis) at screening. 3) Participants with a history of drug allergic reactions, or known or suspected sensitivity to any component in the investigational medicinal product (IMP). 4) Participants with abnormal liver function test results at screening and at admission (for liver function, any of the values of AST, ALT, or total bilirubin exceeding the upper limit of normal). However, this does not apply if the investigator or subinvestigator determines that it is not clinically significant. 5) Participants with a history of malignant tumor within 5 years prior to screening, excluding appropriately treated basal cell carcinoma or squamous cell carcinoma. 6) Participants with any clinically significant 12-lead electrocardiogram (ECG) findings at screening and at admission. For example, atrioventricular block, PR interval >200 ms, QRS interval >120 ms, and QTcF interval >=450 ms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic: - Plasma concentrations of JNT-517 - Pharmacokinetic parameters of JNT-517 | — |
Contacts
Public ContactDrug Information Center
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed