Study of [14C]CS0159 in China Healthy Subjects

Cascade Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Primary Biliary Cholangitis

Treatments: Drug: [14C]CS0159

Study type: Interventional

Funder types: Other

Identifiers

NCT06098027

CS0159-001B

Details and patient eligibility

About

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

Full description

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

Enrollment: 6 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

[14C]CS0159

Experimental group

Description:

Single oral dose of 4mg \[14C\]CS0159

Treatment:

Drug: [14C]CS0159