[Translation] A Phase I, open-label study evaluating the effects of fluconazole and rifampin on the pharmacokinetics of HL-1186, the effects of HL-1186 on the pharmacokinetics of midazolam, and the pharmacokinetics of HL-1186 and metformin in healthy adult trial participants.
主要目的:
? 评估健康成年试验参与者多次口服氟康唑(CYP2C9中效抑制剂)对HL-1186药代动力学(PK)的影响;
? 评估健康成年试验参与者多次口服利福平(CYP2C9中效诱导剂)对HL-1186 PK的影响;
? 评估健康成年试验参与者多次口服HL-1186对咪达唑仑(CYP3A4底物)及其主要代谢产物1-OH咪达唑仑PK的影响;
? 评估健康成年试验参与者多次口服HL-1186和二甲双胍PK的相互影响。
次要目的:
? 评估在健康成年试验参与者中HL-1186单药或联合给药后HL-1186及其主要代谢产物HL-1192的PK特征;
? 分别评估健康成年试验参与者多次口服氟康唑(CYP2C9中效抑制剂)、利福平(CYP2C9中效诱导剂)、二甲双胍对HL-1186主要代谢产物HL-1192 PK的影响;
? 评估在健康成年试验参与者中HL-1186对咪达唑仑及其主要代谢产物1-OH咪达唑仑、二甲双胍的其他PK参数的影响;
? 评价在健康成年试验参与者中HL-1186单药或联合给药的安全性和耐受性。
[Translation] Primary Objectives:
* To evaluate the effect of repeated oral administration of fluconazole (a CYP2C9 intermediate-acting inhibitor) on the pharmacokinetics (PK) of HL-1186 in healthy adult trial participants;
* To evaluate the effect of repeated oral administration of rifampin (a CYP2C9 intermediate-acting inducer) on the PK of HL-1186 in healthy adult trial participants;
* To evaluate the effect of repeated oral administration of HL-1186 on the PK of midazolam (a CYP3A4 substrate) and its major metabolite 1-OH midazolam in healthy adult trial participants;
* To evaluate the interaction between repeated oral administration of HL-1186 and metformin on the PK of healthy adult trial participants.
Secondary Objectives:
* To evaluate the PK characteristics of HL-1186 and its major metabolite HL-1192 after monotherapy or combination therapy in healthy adult trial participants;
* Evaluate the effects of repeated oral administration of fluconazole (a CYP2C9 intermediate-acting inhibitor), rifampin (a CYP2C9 intermediate-acting inducer), and metformin on the pharmacokinetic (PK) of HL-1186's major metabolite, HL-1192, in healthy adult trial participants;
Evaluate the effects of HL-1186 on other PK parameters of midazolam and its major metabolite 1-OH midazolam, and metformin in healthy adult trial participants;
Evaluate the safety and tolerability of HL-1186 as a monotherapy or in combination therapy in healthy adult trial participants.