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歌禮制藥-B(01672.HK):THRβ激動劑ASC41健康受試者藥物相互作用和非酒精性脂肪性肝病患者藥代動力學美國I期臨牀試驗取得良好頂線數據
格隆匯 09-08 08:06

格隆匯9月8日丨歌禮制藥-B(01672.HK)發佈公吿,公司全資附屬甘萊製藥有限公司的肝臟靶向性前體藥物ASC41口服片劑健康受試者藥物相互作用和非酒精性脂肪性肝病(NAFLD)患者藥代動力學(PK)美國I期臨牀試驗取得良好頂線數據。ASC41主要通過CYP3A4代謝形成活性代謝物ASC41-A,ASC41-A是一種選擇性甲狀腺激素β受體(THRβ)激動劑。

該項臨牀研究由兩個隊列組成。第一個隊列評估了健康受試者口服5mg ASC41片劑並同時使用伊曲康唑(CYP3A4強抑制劑)或苯妥英(CYP3A4強誘導劑)的安全性、耐受性和藥代動力學。第二個隊列評估了NAFLD患者口服5mg ASC41片劑的安全性、耐受性和藥代動力學。

該項研究還顯示,ASC41/ASC41-A的藥代動力學特徵在健康受試者與NAFLD患者中無顯着差異。此外,該項美國研究的藥代動力學結果與ASC41中國I期研究的結果相當,表明該藥物在中美羣體之間未存在顯着的藥代動力學差異。

這些結果非常重要,對於正在服用SSRIs/SNRIs和他汀類藥物的NASH患者,將可以參與即將開展的ASC41臨牀研究。此外,這些結果也可能轉化為在真實世界中NASH患者的藥物易用性,因為這些患者通常還需服用許多藥物來控制其併發症,如高脂血症、二型糖尿病和抑鬱症。

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