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Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects

NCT05660720 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-12-21

No results posted yet for this study

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

Conditions

  • Healthy Subject

Interventions

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)

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-19
Primary Completion
2023-06-30
Completion
2023-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660720 on ClinicalTrials.gov