[Translation] A single-center, randomized, double-blind/open phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of W1302 tablets in Chinese healthy adult and elderly subjects, with single or multiple doses on an empty stomach or a single dose after meals
主要目的:
评估在中国健康成年受试者进行空腹单多剂和餐后单剂口服以及健康老年受试者空腹单剂口服W1302片的安全性和耐受性。
次要目的:
(1)评估在中国健康成年受试者进行空腹单多剂口服以及健康老年受试者空腹单剂口服W1302片的药代动力学(PK)特征;
(2)评估进食对中国健康成年受试者单剂口服W1302片PK影响。
探索性目的:
(1)评价W1302片单剂口服给药后对中国健康受试者QT/QTc间期的影响;
(2)初步探索在中国健康成年受试者进行空腹单多剂口服以及健康老年受试者空腹单剂口服W1302片的药效学(PD)特征;
(3)初步探索W1302片在体内的代谢及排泄途径。
[Translation] Primary objective:
To evaluate the safety and tolerability of W1302 tablets in single or multiple doses and single doses after meals in healthy Chinese adult subjects and single doses in healthy elderly subjects.
Secondary objectives:
(1) To evaluate the pharmacokinetic (PK) characteristics of W1302 tablets in single or multiple doses in healthy Chinese adult subjects and single doses in healthy elderly subjects;
(2) To evaluate the effect of single doses of W1302 tablets in healthy Chinese adult subjects on the PK.
Exploratory objectives:
(1) To evaluate the effect of single doses of W1302 tablets on the QT/QTc interval in healthy Chinese subjects;
(2) To preliminarily explore the pharmacodynamic (PD) characteristics of W1302 tablets in single or multiple doses in healthy Chinese adult subjects and single doses in healthy elderly subjects;
(3) To preliminarily explore the metabolism and excretion pathways of W1302 tablets in vivo.