A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects (NCT05088642) | Clinical Trial Compass
CompletedPhase 1
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
China24 participantsStarted 2020-09-28
Plain-language summary
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as age-, weight-, and gender-matched subjects with normal hepatic function.
Who can participate
Age range18 Years ā 65 Years
SexALL
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
ā. Sign the informed consent form before the study and fully understand the study content, process, and possible adverse reactions; able to complete the study as required by the clinical study protocol;
ā. Subjects (and their partners) are willing to adopt effective contraceptive measures from screening to 6 months after the last study administration. See Appendix 1 for specific contraceptive measures;
ā. Aged 18-65 years (inclusive), male or female;
ā. Body mass index (BMI = weight (kg)/height2 (m2)): 18-30 kg/m2 (inclusive);
ā. For subjects with normal hepatic function: normal or abnormal but not clinically significant laboratory findings (hematology, blood biochemistry, urinalysis, and coagulation function);
ā. For subjects with normal hepatic function: no history of severe primary disorders involving major organs, including but not limited to the gastrointestinal, respiratory, renal, hepatic, neural, hematological, endocrine, neoplastic, immunological, psychiatric, or cardiovascular and cerebrovascular disorders.
ā. Have not received medication within 4 weeks before screening, or have received stable medication for at least 4 weeks for hepatic impairment and/or other concurrent diseases requiring long-term treatment;
ā. With Child-Pugh Class A or B hepatic insufficiency caused by prior primary liver disorders (except drug-induced liver diseases).
Exclusion criteria
ā. Average daily consumption of \> 5 cigarettes within 3 months before screening;
What they're measuring
1
Peak plasma concentration (Cmax)
Timeframe: 0-120 hours post dose
2
Area Under the plasma concentration vs time curve (AUC0-120).
Timeframe: 0-120 hours post dose
3
Area under the blood concentration vs time curve (AUC0-inf).
. Allergic constitution, or allergy to any component of hetrombopag olamine tablets;
ā. Average daily alcohol consumption of \> 15 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) and \> 25 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 3 months before screening;
ā. History of drug abuse within 3 months before screening;
ā. Have donated or lost ā„ 400 mL of blood, or have received blood transfusion within 3 months before screening;
ā. Have undergone major surgery within 6 months before screening, or with incomplete healing of surgical incision;
ā. History of deep vein thrombosis or other thromboembolic events, or clinical symptoms suggesting thrombophilia;
ā. Have received TPO receptor agonists (such as eltrombopag and romiplostim) or TPO within 1 month before screening;