Study of [14C]CS0159 in China Healthy Subjects

Primary Biliary Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098027
• Other study ID #: CS0159-001B
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2023
• Est. completion date: November 2, 2023

Study information

• Verified date: October 2023
• Source: Cascade Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• [14C]CS0159
Single oral administration of 4mg [14C]CS0159

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Cascade Pharmaceuticals, Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass Balance	Mass balance recovery of total radioactivity in urine and fecal samples.	Screening period (-48 hours) to 240 hours
Primary	[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
Primary	Radioactivity of CS0159	Whole blood to plasma total radioactivity ratio	Up to 90 hours post dose
Primary	Area under the curve	Total radioactivity in plasma PK: AUC	Up to 90 hours post dose
Primary	Highest radioactivity observed plasma concentration	Total radioactivity in plasma PK: Cmax	Up to 90 hours post dose
Primary	Time for Cmax	Total radioactivity in plasma PK: Tmax	Up to 90 hours post dose
Primary	Elimination half-life	Total radioactivity in plasma PK: T1/2	Up to 90 hours post dose
Secondary	Blood plasma PK	other major metabolites in plasma( if any).	Up to 90 hours post dose
Secondary	Adverse events	All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs	Up to 240 hours post dose
Secondary	AUC of CS0159	Area under the plasma concentration time curve of CS0159	Up to 90 hours post dose
Secondary	Cmax of CS0159	Highest observed plasma concentration of CS0159	Up to 90 hours post dose
Secondary	T1/2 of CS0159	Elimination half-life of CS0159	Up to 90 hours post dose
Secondary	Tmax of CS0159	Time for Cmax of CS0159	Up to 90 hours post dose