UnknownPhase 1

Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects

China48 participantsStarted 2022-11-19

Plain-language 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

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. After being informed and understanding of the trial process and possible adverse reactions of the drug, the subjects voluntarily signed an informed consent form (ICF) and confirmed their participation in all study procedures;
✓. Healthy subjects aged 18-45 years (inclusive) at the time of signing the informed consent;
✓. Weight of subjects ≥50.0 kg and ≤100.0 kg; Body mass index (BMI) ≥19.0 kg/m2 and ≤ 30.0 kg/m2, BMI= weight (kg)/height 2 (m2);
✓. Subjects do not have clinically meaningful medical history and various examinations including physical examination, vital signs, laboratory tests or ECG, and the results are normal or abnormal without clinical significance judged by investigators.
✓. Eligible fertile subjects (male and female) must agree to abstain from sex (avoid heterosexual sex) or use effective contraceptives with an annual contraceptive failure rate of less than 1% during the trial period until 3 months after the end of the trial.

Exclusion criteria

✕. History of any clinically serious disease like heart, liver, kidney, gastrointestinal tract, blood and respiratory system, immune system etc, with a history of fainting during acupuncture or injection or when seeing blood, or cannot tolerate venipuncture;
✕. Abnormal renal ,liver and pancreas function;
✕. Low blood pressure (systolic blood pressure\<90 mmHg; diastolic blood pressure\<60 mmHg) or hypertension (systolic blood pressure ≥ 140 mmHg; diastolic blood pressure ≥ 90 mmHg);
✕. Prolonged QTc interval that is at risk of causing torsade de pointes (TdP) requires drug treatment or other heart related abnormalities require drug treatment;
✕. The average value of three repetitions of 12 lead ECG at screening and before the first administration exceeded the standard: PR\>220 ms, QRS\>120 ms, HR\<50 bpm, QTcF\>450 ms (male and female), and any ECG abnormality with clinical significance determined by the investigator at screening;
✕. With a history of dysphagia or any gastrointestinal disease that affects drug absorption;
✕. With a history of drug or food allergy, or a history of specific allergies (asthma, urticaria, eczema, etc.); or allergic to moxifloxacin or other fluoroquinolones;
✕. Within 3 months before screening, those who have undergone surgery, have smoked more than 5 cigarettes or e-cigarettes daily, with a history of drug abuse or illicit drug use, or plan to undergo surgery during the study period, or with positive results of urine drug test at screening;

What they're measuring

Placebo-corrected change-from-baseline QTcF interval

Timeframe: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17

Trial details

NCT IDNCT05660720

SponsorBeijing InnoCare Pharma Tech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Healthy Subject trials