Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2023-10-23
2023-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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[14C]CS0159
Single oral dose of 4mg \[14C\]CS0159
[14C]CS0159
Single oral administration of 4mg \[14C\]CS0159
Interventions
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[14C]CS0159
Single oral administration of 4mg \[14C\]CS0159
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
MALE
Yes
Sponsors
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Cascade Pharmaceuticals, Inc
OTHER
Responsible Party
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Principal Investigators
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Deng Rong
Role: STUDY_DIRECTOR
Cascade Pharmaceuticals, Inc
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Other Identifiers
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CS0159-001B
Identifier Type: -
Identifier Source: org_study_id