A phase I study of HEC73543, an oral FLT3 inhibitor: the effect of food on pharm...

연구 요약

A phase I study of HEC73543, an oral FLT3 inhibitor: the effect of food on pharmacokinetics after oral dosing in healthy Chinese volunteers.

Frontiers in pharmacology 학술지에 발표된 이 연구는 Wang D, Wu M, Li X 외 연구팀이 수행하였습니다.

이 연구는 'A phase I study of HEC73543, an oral FLT3 inhibitor: the effect of food on pharmacokinetics after oral dosing in healthy Chinese volunteers.'에 대한 과학적 분석을 제공합니다.

핵심 내용

OBJECTIVE: This study evaluated the effect of food on the pharmacokinetics (PK) and safety of HEC73543. METHODS: This randomized, open-label, single-dose, phase I parallel trial included 40 healthy subjects randomized (1:1) to either high-fat or fasted groups. Participants received a single oral dose of 40 mg HEC73543. Blood samples were collected and detected using a validated liquid chromatography tandem mass spectrometry method. PK parameters were calculated using non-compartmental methods. Safety was monitored throughout the study. RESULTS: For the HEC73543, the fed-to-fasted ratios were: area under the curve from time 0 to time t (AUC0-t), 219.42% (90% confidence interval [CI]: 173.76, 277.08%); AUC from zero to infinity ( AUC 0 - ∞ ), 255.22% (90% CI: 198.10, 328.80%); and maximum concentration (Cmax), 221.31% (90%CI: 190.57, 257.00%). Similarly, for the metabolite M3, the fed-to-fasted ratios were: AUC0-t, 190.86% (90%CI: 153.26%, 237.68%); AUC 0 - ∞ , 190.29% (90% CI: 151.77%, 238.59%); and Cmax, 177.48% (90% CI: 137.80%, 228.58%). Median Tmax of HEC73543 were comparable between the two groups. The most frequently Treatment-Related Adverse Events (TRAEs) were elevated blood triglycerides, oral ulceration, hyperuricemia, diarrhea, thoracalgia. Most TRAEs were Grade 1 or 2. CONCLUSION: High-fat food intake enhanced bioavailability and increases the systemic exposure levels of HEC73543 and its metabolite M3. CLINICAL TRIAL REGISTRATION: NCT05454098 (http://www.clinicaltrials.gov/).

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