Phase I Clinical Study of S-001000 Multiple Doses(twice-daily oral administration)

JRCT ID: jRCT2071210091

Registered date:05/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gout and Hyperuricemia
• Date of first enrollment: 27/10/2021
• Target sample size: 12
• Study type: Interventional
• Intervention(s): The drugs of S-001000 or S-001000 placebo were administrated by a multiple oral dose twice-daily

Outcome(s)

Primary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

(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.

Exclude 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.

Related Information

• Primary Sponsor: Tsubouchi Ichiro