Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy

Status Active, not recruiting

Clinical Trial Summary

This is A Randomized, Blinded, Placebo- and Positive-Controlled, Four-Period, Crossover-Design Thorough QT/QTc (TQT) Study to Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects

Clinical Trial Description

This is a randomized, blinded, placebo- and positive-controlled, four-period, crossover clinical study. A double-blind design is used for administration of orelabrutinib tablet and placebo, and an open-label design is used for moxifloxacin hydrochloride tablet.Subjects who meet all inclusion criteria and do not meet any of the exclusion criteria are randomly assigned to one of 12 treatment sequences, and each treatment sequence includes 4 periods, with a 5-day washout period between treatment periods. The subject will complete all the visit examinations on Day 17 after the first dose, then will be discharged from the study site, and will receive telephone follow-up on Day 8 ± 2 after the last dose date. If a subject has clinically significant abnormal examination results when discharging from the study site after the last dose, on-site follow-up is essential to track the abnormal examination results, or otherwise, only telephone follow-up is required. ;

Study Design

Related Conditions & MeSH terms

Healthy Subject

Clinical Trial Details

NCT number	NCT05660720
Study type	Interventional
Source	Beijing InnoCare Pharma Tech Co., Ltd.
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	November 19, 2022
Completion date	August 31, 2023

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