Clinical trial NCT06098027: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Biliary Cholangitis
Lead sponsor: Cascade Pharmaceuticals, Inc
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Primary outcomes:
measure: Mass Balance
timeFrame: Screening period (-48 hours) to 240 hours
measure: [14C] CS0159 metabolite
timeFrame: Screening period (-48 hours) to 240 hours
measure: Radioactivity of CS0159
timeFrame: Up to 90 hours post dose
measure: Area under the curve
timeFrame: Up to 90 hours post dose
measure: Highest radioactivity observed plasma concentration
timeFrame: Up to 90 hours post dose
measure: Time for Cmax
timeFrame: Up to 90 hours post dose
measure: Elimination half-life
timeFrame: Up to 90 hours post dose
Secondary outcomes:
measure: Blood plasma PK
timeFrame: Up to 90 hours post dose
measure: Adverse events
timeFrame: Up to 240 hours post dose
measure: AUC of CS0159
timeFrame: Up to 90 hours post dose
measure: Cmax of CS0159
timeFrame: Up to 90 hours post dose
measure: T1/2 of CS0159
timeFrame: Up to 90 hours post dose
measure: Tmax of CS0159
timeFrame: Up to 90 hours post dose
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Cascade Pharmaceuticals, Inc
name: Deng Rong
role: STUDY_DIRECTOR
References: