CompletedPhase 1

A Trial of Hetrombopag in Healthy Subjects

China26 participantsStarted 2020-09-03

Plain-language summary

This is a single-center, single-arm, open-label, self-controlled, phase I clinical study. A total of 26 male or female healthy subjects are intended to be enrolled to evaluate the PK drug-drug interaction between ciclosporin and hetrombopag.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
✓. Male or female subjects aged 18-55 years (inclusive);
✓. Body mass index (BMI) between 18 and 26 kg/m2 (inclusive);
✓. Normal or abnormal but not clinically significant physical examination and laboratory test results; normal or abnormal but not clinically significant ECG;
✓. Have no plan for pregnancy and agree to take effective contraceptive measures from signing of informed consent form until 6 months after the last dose;
✓. Able to maintain a consistency of good communication with the investigators, and understand and comply with all the requirements of this study

Exclusion criteria

✕. Any previous or current serious clinical conditions of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, and hematological, immunological, psychiatric and metabolic abnormalities, or any disease that may interfere with the results of this study;
✕. History of deep venous thrombosis or other thrombotic disorders;
✕. QTc \> 450 ms in males or QTc \> 460 ms in females through 12-lead ECG examination with clinical significance per the investigator's judgment at screening;
✕. Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody (trust), or HIV antibody;
✕. Positive pregnancy test result;
✕. Allergic constitution, or allergy to any component of hetrombopag olamine tablets and ciclosporin capsules;
✕. Have received surgery within 4 weeks before the first study administration, or plan to undergo surgery during the course of the study;
✕. Have taken any drug that alters liver enzyme activity within 28 days before the first study administration or during the study;

What they're measuring

Peak hetrombopag plasma concentration (Cmax)

Timeframe: 0-120 hours post dose

Area Under the plasma hetrombopag concentration vs time curve (AUC0-120)

Timeframe: 0-120 hours post dose

Area under the plasma hetrombopag concentration vs time curve (AUC0-inf)

Timeframe: 0-infinity

Trial details

NCT IDNCT05088174

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-22

View on ClinicalTrials.gov More Sever Aplastic Anaemia trials