Phase I study of N-(2-mercapto-2-methylpropionyl)-L-cysteine (SA96). II. Continuous 6-day administration study.

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The multiple dose Phase I study was performed on SA96 in 5 healthy volunteers.300 mg/day and 600 mg/day of SA96 were administered t. i. d. after meals for 6 days consecutively after 2 weeks washout. The following results were obtained. 1) No remarkable subjective complaint was registered except for belching. 2) No significant anomaly was noted in clinical symptoms or laboratory values. 3) The changes in blood concentration of SA96 followed the same pattern as the single dose study, that is the drug was rapidly absorbed in the blood and rapidly excreted without accumulation. 4) Little difference was noted in urinary excretion pattern between day 1 and day 6, and 39-46% of the amount administered was excreted into the urine by 24 hours after the first administration on each day. SA96 was not detected in the urine on the day after finishing the administration, but trace amou ts of SA679 was found for 2 days thereafter. Since the Phase I studies confirmed the safety of SA96 in the range of single doses at 200 mg and 6 consecutive days of doses at 600 mg/day, it is adjudged possible to proceed to a Phase II study to evaluate the effectiveness, safety, and usefulness of the drug on rheumatoid arthritis.
一般社団法人日本臨床薬理学会の論文