Prospective, single-center, randomized, double-blind, placebo-controlled, two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses of lucerastat on the QT/QTc interval duration in healthy subjects - CS0311 (ID-069-106)

Idorsia Pharmaceuticals Ltd0 个研究点目标入组 44 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•Part A only
•1. Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.;Part B only
•2. Healthy male and female subjects aged between 18 and 55 years (inclusive) at Screening.;Part A and B
•3. Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
•4. Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening. Body weight at least 50.0 kg at Screening and prior to first study treatment administration.;Further inclusion criteria can be found in the protocol section 3.2.2

•Part B only
•1. Known hypersensitivity to moxifloxacin or any of its excipients. ;Part A and B
•2. Previous exposure to lucerastat.
•3. Known hypersensitivity to any of lucerastat*s excipients.
•4. Known hypersensitivity or allergy to natural rubber latex.;Further exclusion criteria can be found in the protocol section 3.2.3.

发起方