NCT05660720

Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
DRUG	Orelabrutinib and placebo (orelabrutinib tablet simulator)	Orelabrutinib will be administered as 3 tablets (150mg) and placebo as 5 tablets (250mg)
DRUG	Orelabrutinib	Orelabrutinib will be administered as 8 tablets (400mg)
DRUG	Placebo (orelabrutinib tablet simulator)	Placebo will be administered as 8 tablets (400mg).
DRUG	Moxifloxacin hydrochloride	Moxifloxacin hydrochloride will be administered as 1 tablet (400mg)

Timeline

• Start date: 2022-11-19
• Primary completion: 2023-06-30
• Completion: 2023-08-31
• First posted: 2022-12-21
• Last updated: 2022-12-21

Locations

1 site across 1 country: China