A Trial of Hetrombopag in Healthy Subjects (NCT05088174) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak hetrombopag plasma concentration (Cmax)
Timeframe: 0-120 hours post dose
2
Area Under the plasma hetrombopag concentration vs time curve (AUC0-120)
Timeframe: 0-120 hours post dose
3
Area under the plasma hetrombopag concentration vs time curve (AUC0-inf)
. 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;