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

NCT06888115 | Completed Phase 1 FDA Drug

• 1 other identifier: CS0159-HI-CN-I-05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Primary Biliary Cholangitis

Outcome Measures

Primary Outcomes (8)

• Pharmacokinetic parameters of CS0159 (Cmax)

  Peak concentration

  Day1 to day3

• Pharmacokinetic parameters of CS0159 (AUC0-t)

  Area under the concentration-time curve from time zero to the last measurable concentration

  Day1 to day3

• Pharmacokinetic parameters of CS0159 (AUC0-∞)

  Area under the curve from time 0 extrapolated to infinite time

  Day1 to day3

• Pharmacokinetic parameters of CS0159 (Tmax)

  Time to peak concentration

  Day1 to day3

• Pharmacokinetic parameters of CS0159 (t1/2)

  Eliminate terminal half-life

  Day1 to day3

• Pharmacokinetic parameters of CS0159 (CL/F)

  Apparent clearance

  Day1 to day3

• Pharmacokinetic parameters of CS0159 (MRT)

  Mean Residence Time

  Day1 to day3

• Pharmacokinetic parameters of CS0159 (Vz/F)

  (Vz/F)

  Day1 to day3

Secondary Outcomes (1)

• Safety evaluation endpoints

  Baseline to Day 7

Study Arms (3)

Guoup 1

EXPERIMENTAL

Single oral dose of CS0159 in subjects with Child-Pugh Grade A

Drug: CS0159

Guoup 2

EXPERIMENTAL

Single oral dose of CS0159 in subjects with Child-Pugh Grade B

Drug: CS0159

Guoup 3

EXPERIMENTAL

Single oral dose of CS0159 in healthy subjects with normal liver function

Drug: CS0159

Interventions

CS0159 DRUG

Single oral dose of CS0159 4mg

Guoup 1; Guoup 2; Guoup 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• Subjects with resting heart rate \>100 bpm (allow retesting 2 times).
• Subjects positive for HIV antibody (HIV-Ab) testing.
• Within 4 weeks prior to drug dosing, subjects who have used herbal medicines or any drugs that may affect CYP3A enzyme activity (such as CYP3A inducers, i.e., barbiturates, carbamazepine, glucocorticoids, etc.; inhibitors, i.e., SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, etc.).
• Subjects who have taken any medications (including herbal medicines, vitamins, and health supplements) within 14 days before dosing (or 5 half-lives, whichever is longer), except for stable medications in subjects with hepatic impairment.
• Subjects who have participated in other clinical trials and received investigational products or medical devices within 1 month prior to screening, using the date of the last dosing in the clinical study as the time reference (if the clinical study drug has a long half-life, at least 5 half-lives must have elapsed between dosing in that study and dosing in this study).
• Subjects who have experienced blood loss or blood donation of ≥400 mL within 3 months prior to dosing, or plan to donate blood within 1 month after the end of this trial.
• Subjects who are addicted to smoking, or smoked more than 5 cigarettes per day within 3 months prior to screening, or unable to stop any tobacco product use during the study period.

Sponsors & Collaborators

• Cascade Pharmaceuticals, Inc: lead

Study Sites (3)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhao wei feng, Master

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 21, 2025
• Study Start: March 13, 2025
• Primary Completion: May 29, 2025
• Study Completion: June 3, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (3)