A Clinical Study to Evaluate the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects With Impaired Liver Function Versus Normal Liver Function

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function

Eligibility criteria

Qualifiers

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;

Disqualifiers

Suffering from primary diseases of major organs, including but not limited to gastrointestinal, respiratory, renal, neurological, hematological, endocrine, oncological, immune, psychiatric, or cardiovascular diseases, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);

Physical examination, vital signs, or clinical laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function) show abnormalities of clinical significance, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);

Participated in any drug clinical trial and used any investigational drug within 3 months prior to screening;

Tested positive for HIV or syphilis screening;

Trial design

Treatments tested in this trial

  • Anecatibin Fumarate Capsules

Treatment groups

24 Participants
are divided into 1 treatment group