Gout and Hyperuricemia
Conditions
Interventions
The drugs of S-001000 or S-001000 placebo were administrated by a multiple oral dose twice-daily
Sponsors
Tsubouchi Ichiro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1)Japanese healthy male aged >= 20 and = 18.5 kg/m2 to < 28.0 kg/m2. (3)Subjects considered healthy by the investigator/subinvestigator based on the results of screening examination, and medical examination and all tests performed after admission and before study drug administration. (4)Subjects who are fully informed of the study objectives, contents, and study drug, and voluntarily provide a written consent to participate in the study.
Exclusion criteria
Exclusion criteria: (1)Subjects with a current or past history of a clinically concerned gastrointestinal, hepatic, musculoskeletal, respiratory, cerebrovascular or cardiovascular, hematological, oncological, endocrine, immunological, psychiatric, neurological, or urogenital disease, or any condition that, in the opinion of the investigator/subinvestigator, would compromise the subject's safety or interfere with this study results. (2)Subjects with a current or past history of urinary calculus. (3)Subjects with a history of surgery or a current internal medical condition that, in the opinion of the investigator/subinvestigator, may interfere with drug absorption, distribution, metabolism, or excretion. (4)Otherwise, subjects who are judged by the investigator/subinvestigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints (1)AEs and adverse drug reactions (ADRs) (2)Laboratory values (hematology, clinical chemistry, and urinalysis) (3)Vital signs (blood pressure, pulse rate, and body temperature) (4)12-lead ECG Pharmacokinetic Endpoints Each PK parameter of unchanged S-001000 and its metabolites will be calculated from the plasma or urine drug concentration. | — |
Contacts
Public ContactClinical Trials Information Desk
Sato Pharmaceutical Co., Ltd.
Outcome results
None listed