Back to resultsStudy of [14C]CS0159 in China Healthy Subjects
Primary Purpose
Primary Biliary Cholangitis
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
[14C]CS0159
Sponsored by
About this trial
This is an interventional other trial for Primary Biliary Cholangitis
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Soochow University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[14C]CS0159
Arm Description
Single oral dose of 4mg [14C]CS0159
Outcomes
Primary Outcome Measures
Mass Balance
Mass balance recovery of total radioactivity in urine and fecal samples.
[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.
Radioactivity of CS0159
Whole blood to plasma total radioactivity ratio
Area under the curve
Total radioactivity in plasma PK: AUC
Highest radioactivity observed plasma concentration
Total radioactivity in plasma PK: Cmax
Time for Cmax
Total radioactivity in plasma PK: Tmax
Elimination half-life
Total radioactivity in plasma PK: T1/2
Secondary Outcome Measures
Blood plasma PK
other major metabolites in plasma( if any).
Adverse events
All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs
AUC of CS0159
Area under the plasma concentration time curve of CS0159
Cmax of CS0159
Highest observed plasma concentration of CS0159
T1/2 of CS0159
Elimination half-life of CS0159
Tmax of CS0159
Time for Cmax of CS0159
Full Information
NCT ID
NCT06098027
First Posted
September 21, 2023
Last Updated
October 18, 2023
Sponsor
Cascade Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT06098027
Brief Title
Study of [14C]CS0159 in China Healthy Subjects
Official Title
[14C]CS0159 in Chinese Healthy Subjects for Mass Balance Phase I Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cascade Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study of [14C]CS0159 in China Healthy Subjects.
Detailed Description
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]CS0159.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[14C]CS0159
Arm Type
Experimental
Arm Description
Single oral dose of 4mg [14C]CS0159
Intervention Type
Drug
Intervention Name(s)
[14C]CS0159
Intervention Description
Single oral administration of 4mg [14C]CS0159
Primary Outcome Measure Information:
Title
Mass Balance
Description
Mass balance recovery of total radioactivity in urine and fecal samples.
Time Frame
Screening period (-48 hours) to 240 hours
Title
[14C] CS0159 metabolite
Description
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.
Time Frame
Screening period (-48 hours) to 240 hours
Title
Radioactivity of CS0159
Description
Whole blood to plasma total radioactivity ratio
Time Frame
Up to 90 hours post dose
Title
Area under the curve
Description
Total radioactivity in plasma PK: AUC
Time Frame
Up to 90 hours post dose
Title
Highest radioactivity observed plasma concentration
Description
Total radioactivity in plasma PK: Cmax
Time Frame
Up to 90 hours post dose
Title
Time for Cmax
Description
Total radioactivity in plasma PK: Tmax
Time Frame
Up to 90 hours post dose
Title
Elimination half-life
Description
Total radioactivity in plasma PK: T1/2
Time Frame
Up to 90 hours post dose
Secondary Outcome Measure Information:
Title
Blood plasma PK
Description
other major metabolites in plasma( if any).
Time Frame
Up to 90 hours post dose
Title
Adverse events
Description
All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs
Time Frame
Up to 240 hours post dose
Title
AUC of CS0159
Description
Area under the plasma concentration time curve of CS0159
Time Frame
Up to 90 hours post dose
Title
Cmax of CS0159
Description
Highest observed plasma concentration of CS0159
Time Frame
Up to 90 hours post dose
Title
T1/2 of CS0159
Description
Elimination half-life of CS0159
Time Frame
Up to 90 hours post dose
Title
Tmax of CS0159
Description
Time for Cmax of CS0159
Time Frame
Up to 90 hours post dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miao li Yan, Doctor
Phone
0512-67972858
Email
miaolysuzhou@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deng Rong
Organizational Affiliation
Cascade Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miao li Yan, Doctor
Phone
0512-67972858
Email
miaolysuzhou@163.com
12. IPD Sharing Statement
Learn more about this trial
Study of [14C]CS0159 in China Healthy Subjects
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