Phase I Clinical Study of S-001000 Multiple Doses(twice-daily oral administration)
- Conditions
- Gout and Hyperuricemia
- Registration Number
- JPRN-jRCT2071210091
- Lead Sponsor
- Tsubouchi Ichiro
- Brief Summary
o problem was observed in the safety and tolerability of repeated oral administration of S-001000 30 to 120 mg/day twice daily for total 20 days by a dose-escalation method. Cmax and AUC increased in proportion to the dose and their linearity were observed. Steady state was almost reached after the second dosing day of each dose level and no accumulation was observed based on pharmacokinetics such as Ctrough and R. The reduction in serum uric acid levels was maintained in terms of pharmacodynamics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 12
(1)Japanese healthy male aged >= 20 and <= 45 years at the time of informed consent.
(2)Subjects with screening body mass index (BMI) >= 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.
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Endpoints<br>(1)AEs and adverse drug reactions (ADRs)<br>(2)Laboratory values (hematology, clinical chemistry, and urinalysis)<br>(3)Vital signs (blood pressure, pulse rate, and body temperature)<br>(4)12-lead ECG<br><br>Pharmacokinetic Endpoints<br>Each PK parameter of unchanged S-001000 and its metabolites will be calculated from the plasma or urine drug concentration.
- Secondary Outcome Measures
Name Time Method