Study of [14C]CS0159 in China Healthy Subjects

Study Overview
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Brief Summary
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Study of [14C]CS0159 in China Healthy Subjects.

Detailed Description
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A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]CS0159.

Official Title
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[14C]CS0159 in Chinese Healthy Subjects for Mass Balance Phase I Study

Conditions
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Primary Biliary Cholangitis

Intervention / Treatment
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* Drug: [14C]CS0159


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 18 and 45 years (inclusive). Subjects should not weigh less than 50 kg, BMI between 19 26 kg/㎡. No sperm donation or fertility plan during the study and within 12 months after the end of the study. Understand the purpose and requirements of trial, subjects who have voluntarily participated in the study and signed the ICF, completion of tests as required. Exclusion Criteria: With abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ECG, chest X-ray, and abdominal ultrasound. 12-ECG QT(QTcF)>450ms. The history of drug allergy. Patients with malabsorption and gastrointestinal disorders or history of Vomiting, diarrhoea in the week prior to the screening period. Patients with difficulty swallowing or interfere with drug absorption. HBs Ag or E antigen, TPAb, or HIV-Ag/Ab positive person. Have taken any clinical trial medication or participated in any other clinical trial within 3 months prior to the screening period. Habitual constipation or diarrhoea. Heavy smokers addicts Heavy drinker addicts. Has drug abuse history or positive drug abuse test results. Heavy caffeine addicts. Special dietary requirements. Poor adherence or any other conditions judged by the investigator as not suitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]CS0159<br>Single oral dose of 4mg [14C]CS0159 | Drug: [14C]CS0159<br>* Single oral administration of 4mg [14C]CS0159<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass Balance | Mass balance recovery of total radioactivity in urine and fecal samples. | Screening period (-48 hours) to 240 hours | 
| [14C] CS0159 metabolite | Identification of the major metabolites of CS0159 in human plasma, urine and faeces, determine the main Determine the main biotransformation pathways and calculate the percentage of the administered dose of the prodrug and each metabolite in urine and faeces, and plasma prodrugs and circulating metabolites as a percentage of total exposure AUC. | Screening period (-48 hours) to 240 hours | 
| Radioactivity of CS0159 | Whole blood to plasma total radioactivity ratio | Up to 90 hours post dose | 
| Area under the curve | Total radioactivity in plasma PK: AUC | Up to 90 hours post dose | 
| Highest radioactivity observed plasma concentration | Total radioactivity in plasma PK: Cmax | Up to 90 hours post dose | 
| Time for Cmax | Total radioactivity in plasma PK: Tmax | Up to 90 hours post dose | 
| Elimination half-life | Total radioactivity in plasma PK: T1/2 | Up to 90 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood plasma PK | other major metabolites in plasma( if any). | Up to 90 hours post dose | 
| Adverse events | All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs | Up to 240 hours post dose | 
| AUC of CS0159 | Area under the plasma concentration time curve of CS0159 | Up to 90 hours post dose | 
| Cmax of CS0159 | Highest observed plasma concentration of CS0159 | Up to 90 hours post dose | 
| T1/2 of CS0159 | Elimination half-life of CS0159 | Up to 90 hours post dose | 
| Tmax of CS0159 | Time for Cmax of CS0159 | Up to 90 hours post dose |