Status:
COMPLETED
Study of [14C]CS0159 in China Healthy Subjects
Lead Sponsor:
Cascade Pharmaceuticals, Inc
Conditions:
Primary Biliary Cholangitis
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06098027
Start Date
October 23 2023
End Date
November 2 2023
Last Update
November 21 2023
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006