Frontiers in pharmacology · 2026
Pharmacokinetics and safety of SHR0302, a selective JAK1 inhibitor, in Chinese patients with hepatic impairment.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Mai Jiajia, Lin Hongda, Wu Min, Wang Di, Zhang Hong, Jin Qinglong, Chen Chong
Аннотация
OBJECTIVE: To evaluate the effects of mild and moderate hepatic impairment on the pharmacokinetics and safety of SHR0302.
METHODS: This open-label, parallel-group study enrolled 24 Chinese subjects, including subjects with normal hepatic function and those with mild or moderate hepatic impairment (8 per group). All subjects received a single oral dose of SHR0302 (8 mg). Plasma PK parameters of SHR0302 and its metabolite, SHR161279, were assessed and compared across groups. Safety was evaluated throughout the study.
RESULTS: Mild hepatic impairment had minimal effect on the exposure of SHR0302. In subjects with moderate hepatic impairment, the Cmax of SHR0302 was approximately 17% lower than that in subjects with normal hepatic function, whereas AUC0-t and AUC 0 - ∞ remained generally unchanged. Meanwhile, exposure to SHR161279 decreased in both hepatic impairment groups, with reductions of approximately 21%-38%. SHR0302 was generally safe after single-dose administration. Eight subjects (8/24, 33.3%) experienced treatment-emergent adverse events (TEAEs). No serious adverse events were reported.
CONCLUSION: Mild and moderate hepatic impairment had minimal effect on SHR0302 exposure. Based on the single-dose pharmacokinetic and safety data, dose adjustment of SHR0302 may not be necessary in patients with mild or moderate hepatic impairment.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier NCT04293029.
METHODS: This open-label, parallel-group study enrolled 24 Chinese subjects, including subjects with normal hepatic function and those with mild or moderate hepatic impairment (8 per group). All subjects received a single oral dose of SHR0302 (8 mg). Plasma PK parameters of SHR0302 and its metabolite, SHR161279, were assessed and compared across groups. Safety was evaluated throughout the study.
RESULTS: Mild hepatic impairment had minimal effect on the exposure of SHR0302. In subjects with moderate hepatic impairment, the Cmax of SHR0302 was approximately 17% lower than that in subjects with normal hepatic function, whereas AUC0-t and AUC 0 - ∞ remained generally unchanged. Meanwhile, exposure to SHR161279 decreased in both hepatic impairment groups, with reductions of approximately 21%-38%. SHR0302 was generally safe after single-dose administration. Eight subjects (8/24, 33.3%) experienced treatment-emergent adverse events (TEAEs). No serious adverse events were reported.
CONCLUSION: Mild and moderate hepatic impairment had minimal effect on SHR0302 exposure. Based on the single-dose pharmacokinetic and safety data, dose adjustment of SHR0302 may not be necessary in patients with mild or moderate hepatic impairment.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier NCT04293029.