CompletedPhase 1

A Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury

China24 participantsStarted 2025-03-13

Plain-language summary

Phase I Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury

Who can participate

Age range18 Years – 75 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

✓. Subjects who fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are able to complete the entire trial process according to the trial requirements.
✓. Subjects aged 18 to 75 years (inclusive) at the time of signing the informed consent form; male or female.
✓. At screening, the weight of male subjects is ≥50 kg, the weight of female subjects is ≥45 kg, and both are ≤100 kg; body mass index \[BMI = weight (kg)/height2 (m2)\] is within 18.0-32.0 kg/m2 (inclusive).
✓. Subjects and their partners agree to have no plans for conception or sperm/egg donation from the signing of the informed consent until 6 months after the last dosing of the study drug and voluntarily take effective contraception measures.
✓. Group 1: subjects with mild hepatic impairment (Child-Pugh Class A, score 5-6), see Appendix 1 for specific scoring.
✓. Group 2: subjects with moderate hepatic impairment (Child-Pugh Class B, score 7-9), see Appendix 1 for specific scoring.
✓. Subjects with hepatic impairment caused by prior primary liver disorders, who have not used albumin within 14 days prior to screening, and have been diagnosed with stable (≥1 month) hepatic impairment through past medical history, physical examination, laboratory tests, or imaging examinations.
✓. Subjects who have not taken any medications within 4 weeks prior to screening, or, for those requiring long-term treatment for hepatic impairment and/or other comorbid diseases, have been on stable medication for at least 4 weeks (stable medication is determined by the investigator, excluding medications prohibited by the protocol).

Exclusion criteria

✕. Subjects known to have a history of allergy to components or excipients of the investigational product, those with an allergic constitution (multiple drug and food allergies), or those with a history of allergic diseases (such as asthma, urticaria, eczema dermatitis, etc.).
✕. Subjects who have a malignant tumor, or a history of malignant tumor regardless of time from diagnosis.
✕. Subjects with severe infection, trauma, intestinal operation, or other major surgery within 4 weeks prior to screening.
✕. Subjects with a history of organic heart disease, cardiac failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, or long QT syndrome, or who have symptoms and family history of long QT syndrome (indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes).
✕. Subjects who have or previously had arrhythmia that requires clinical intervention and may affect survival during the trial; or those with clinically significant electrocardiogram abnormalities at screening \[such as tachycardia/bradycardia requiring drug therapy, second- to third-degree atrioventricular block, or prolonged QTcF interval (male QTcF \> 450 ms, female QTcF \> 470 ms) (corrected using Fridericia's formula), or other clinically significant abnormalities determined by the clinician\].
✕. Serum creatinine \> upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR) calculated using the modification of diet in renal disease (MDRD) formula ˂60 mL/min/1.73 m2.
✕. Subjects who are scheduled for surgery or are likely to require hospitalization during the study period.
✕. Subjects with blood pressure ≥140/90 mmHg (allow retesting 2 times).

What they're measuring

Pharmacokinetic parameters of CS0159 (Cmax)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (AUC0-t)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (AUC0-∞)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (Tmax)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (t1/2)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (CL/F)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (MRT)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (Vz/F)

Timeframe: Day1 to day3

Trial details

NCT IDNCT06888115

SponsorCascade Pharmaceuticals, Inc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-29

View on ClinicalTrials.gov More Primary Biliary Cholangitis trials

Who can participate

Age range18 Years – 75 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

✓. Subjects who fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are able to complete the entire trial process according to the trial requirements.
✓. Subjects aged 18 to 75 years (inclusive) at the time of signing the informed consent form; male or female.
✓. At screening, the weight of male subjects is ≥50 kg, the weight of female subjects is ≥45 kg, and both are ≤100 kg; body mass index \[BMI = weight (kg)/height2 (m2)\] is within 18.0-32.0 kg/m2 (inclusive).
✓. Subjects and their partners agree to have no plans for conception or sperm/egg donation from the signing of the informed consent until 6 months after the last dosing of the study drug and voluntarily take effective contraception measures.
✓. Group 1: subjects with mild hepatic impairment (Child-Pugh Class A, score 5-6), see Appendix 1 for specific scoring.
✓. Group 2: subjects with moderate hepatic impairment (Child-Pugh Class B, score 7-9), see Appendix 1 for specific scoring.
✓. Subjects with hepatic impairment caused by prior primary liver disorders, who have not used albumin within 14 days prior to screening, and have been diagnosed with stable (≥1 month) hepatic impairment through past medical history, physical examination, laboratory tests, or imaging examinations.
✓. Subjects who have not taken any medications within 4 weeks prior to screening, or, for those requiring long-term treatment for hepatic impairment and/or other comorbid diseases, have been on stable medication for at least 4 weeks (stable medication is determined by the investigator, excluding medications prohibited by the protocol).

Exclusion criteria

✕. Subjects known to have a history of allergy to components or excipients of the investigational product, those with an allergic constitution (multiple drug and food allergies), or those with a history of allergic diseases (such as asthma, urticaria, eczema dermatitis, etc.).
✕. Subjects who have a malignant tumor, or a history of malignant tumor regardless of time from diagnosis.
✕. Subjects with severe infection, trauma, intestinal operation, or other major surgery within 4 weeks prior to screening.
✕. Subjects with a history of organic heart disease, cardiac failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, or long QT syndrome, or who have symptoms and family history of long QT syndrome (indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes).
✕. Subjects who have or previously had arrhythmia that requires clinical intervention and may affect survival during the trial; or those with clinically significant electrocardiogram abnormalities at screening \[such as tachycardia/bradycardia requiring drug therapy, second- to third-degree atrioventricular block, or prolonged QTcF interval (male QTcF \> 450 ms, female QTcF \> 470 ms) (corrected using Fridericia's formula), or other clinically significant abnormalities determined by the clinician\].
✕. Serum creatinine \> upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR) calculated using the modification of diet in renal disease (MDRD) formula ˂60 mL/min/1.73 m2.
✕. Subjects who are scheduled for surgery or are likely to require hospitalization during the study period.
✕. Subjects with blood pressure ≥140/90 mmHg (allow retesting 2 times).

What they're measuring

Pharmacokinetic parameters of CS0159 (Cmax)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (AUC0-t)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (AUC0-∞)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (Tmax)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (t1/2)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (CL/F)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (MRT)

Timeframe: Day1 to day3

Pharmacokinetic parameters of CS0159 (Vz/F)

Timeframe: Day1 to day3