Study of [14C]CS0159 in China Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Primary Biliary Cholangitis
• Intervention / Treatment: Drug: [14C]CS0159

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 45 years (inclusive).
2. Subjects should not weigh less than 50 kg, BMI between 19~26 kg/㎡.
3. No sperm donation or fertility plan during the study and within 12 months after the end of the study.
4. 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:

1. With abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ECG, chest X-ray, and abdominal ultrasound.
2. 12-ECG QT(QTcF)>450ms.
3. The history of drug allergy.
4. Patients with malabsorption and gastrointestinal disorders or history of Vomiting, diarrhoea in the week prior to the screening period.
5. Patients with difficulty swallowing or interfere with drug absorption.
6. HBs Ag or E antigen, TPAb, or HIV-Ag/Ab positive person.
7. Have taken any clinical trial medication or participated in any other clinical trial within 3 months prior to the screening period.
8. Habitual constipation or diarrhoea.
9. Heavy smokers addicts
10. Heavy drinker addicts.
11. Has drug abuse history or positive drug abuse test results.
12. Heavy caffeine addicts.
13. Special dietary requirements.
14. Poor adherence or any other conditions judged by the investigator as not suitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]CS0159; Single oral dose of 4mg [14C]CS0159	Drug: [14C]CS0159; Single oral administration of 4mg [14C]CS0159

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cascade Pharmaceuticals, Inc
• Investigators: Study Director: Deng Rong, Cascade Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Actual): November 2, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary
• Other Study ID Numbers: CS0159-001B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No