A Clinical Study to Evaluate the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in S… (NCT07538973) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Study to Evaluate the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects With Impaired Liver Function Versus Normal Liver Function
China24 participantsStarted 2026-04
Plain-language summary
Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All subjects must meet all of the following inclusion criteria:
* Provide signed informed consent prior to trial participation and have a full understanding of the trial content, procedures, and potential adverse reactions;
* Be male or female subjects aged 18 to 65 years (inclusive);
* Weigh at least 50 kg for males and at least 45 kg for females. Body Mass Index (BMI = weight (kg) / height² (m²)) within the range of 18 to 30 kg/m² (inclusive of boundary values);
* Subjects and their partners agree to voluntarily adopt effective contraceptive measures from screening until 6 months after the last dose;
* Subjects are able to communicate well with the investigators and can complete the study according to the study protocol.
Subjects with normal liver function must also meet the following inclusion criteria:
* Negative test results for Hepatitis B surface antigen and Hepatitis C antibody;
* Normal liver function test results or abnormal results without clinical significance;
* Matched with the hepatic impairment group in terms of male-to-female ratio (±1 subject per gender), mean age (±10 years), and mean body weight (±10 kg).
Subjects with hepatic impairment must meet the following inclusion criteria:
* Have a history of or be diagnosed at screening with primary liver disease, including but not limited to: Hepatitis B, Hepatitis C, non-alcoholic fatty liver disease, alcoholic liver disease, etc.;
* Hepatic impairment is caused by a previous primary li…
What they're measuring
1
To determine the Cmax
Timeframe: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
2
To determine the Area Under the Curve (AUC) 0-t
Timeframe: The period extends from the date of the first dose to the completion of the end of treatment (EOT) visit, totaling 5 days
3
To determine the AUC 0-∞
Timeframe: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
Trial details
NCT IDNCT07538973
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.