Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHaisco Pharmaceutical Group Co., Ltd.
About this trial
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HSK39297 in subjects with mild to moderate hepatic impairment and normal hepatic function
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing;
Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female;
At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18~32 kg/m2 (including the threshold);
Normal or abnormal physical examination, 12-ECG, vital signs, chest frontal and lateral radiographs/CT, abdominal ultrasound, and laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, etc.) in the screening and baseline periods were not clinically significant.
Disqualifiers
Smoked an average of more than 5 cigarettes per day in the past 3 months or those who cannot comply with the prohibition of smoking during the trial;
Known or suspected (as judged by the researcher) immunodeficiency diseases or hereditary complement deficiencies;
Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components;
Screen those who have a history of heavy drinking in the past 3 months (with an average daily alcohol consumption of > 2 units of alcohol (1 unit = 285 mL of beer, or 30 mL of spirits, or 100 mL of wine)) or those with a positive breath alcohol test;
Trial design
Design model
Parallel
Treatments tested in this trial
HSK39297 tablets
Drugoral
HSK39297 tablets
Drugoral
HSK39297 tablets
Drugoral
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Treatment group AExperimental treatment 1 intervention
Group B: Treatment group BExperimental treatment 1 intervention
Group C: Treatment group CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cmax
The maximum plasma concentration.
Time frame
Post-dose at day 1 to day 10.2
AUC0-t
Area under the concentration curve from time 0 to the last quantifiable concentration
Time frame
Post-dose at day 1 to day 103
AUC0-inf
Area under the concentration curve from time 0 to extrapolated infinite time
Time frame
Post-dose at day 1 to day 10Secondary outcomes
1
Tmax
Time to maximum plasma concentration
Time frame
Post-dose at day 1 to day 102
t1/2
Terminal half-life
Time frame
Post-dose at day 1 to day 103
CL/F
Apparent clearance
Time frame
Post-dose at day 1 to day 104
Vz/F
Apparent volume of distribution
Time frame
Post-dose at day 1 to day 10Sponsors and contacts
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Source ClinicalTrials.gov