[Translation] A randomized, single- or multiple-dose escalation phase I study evaluating the safety, tolerability, and pharmacokinetic characteristics of HEP-50768 in healthy participants, participants in cholestatic pruritus trials, and participants in chronic kidney disease-associated pruritus trials.
主要目的:评估HEP-50768在健康试验参与者、胆汁淤积性瘙痒试验参与者和慢性肾病相关性瘙痒试验参与者中的安全性和耐受性。
次要目的:评估HEP-50768在健康试验参与者、胆汁淤积性瘙痒试验参与者和慢性肾病相关性瘙痒试验参与者中的药代动力学(PK)特征。评估食物对HEP-50768药代动力学特征的影响和血浆、粪便和尿液中HEP-50768代谢物的鉴定。探索性目的 : 探索HEP-50768在健康试验参与者中单次不同剂量给药后的血药浓度对Fridericia 公式按心率校正的QT间期的影响(C-QTc研究);探索HEP-50768在胆汁淤积性瘙痒试验参与者和慢性肾病相关性瘙痒试验参与者中的药效特征。
[Translation] Primary Objective: To evaluate the safety and tolerability of HEP-50768 in healthy participants, participants in the cholestatic pruritus trial, and participants in the chronic kidney disease-associated pruritus trial.
Secondary Objectives: To evaluate the pharmacokinetic (PK) characteristics of HEP-50768 in healthy participants, participants in the cholestatic pruritus trial, and participants in the chronic kidney disease-associated pruritus trial. To assess the effect of food on the pharmacokinetic characteristics of HEP-50768 and to identify HEP-50768 metabolites in plasma, feces, and urine. Exploratory Objectives: To investigate the effect of single-dose administration of different doses of HEP-50768 on the heart rate-corrected QT interval according to the Fridricia formula in healthy participants (C-QTc study); to investigate the efficacy characteristics of HEP-50768 in participants in the cholestatic pruritus trial and the chronic kidney disease-associated pruritus trial.