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Study to Evaluate the Mass Balance and Biotransformation of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study to Evaluate the Mass Balance and Biotransformation of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers.

A Phase I Mass Balance and Biotransformation Study of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers.

NCT04260373•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

Study to Evaluate the Mass Balance and Biotransformation of Single Dose \[14C\]SHR4640 in Chinese healthy adult male volunteers.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Signing the informed consent forms;
•2. Healthy adult males;
•3. Age: 18 Years to 45 Years(Including the boundary value);
•4. Weight: Body mass index(BMI) between 19 and 26 kg/m2(Including the boundary value);

Exclusion Criteria

•1. Persons with abnormal physical examination, routine laboratory examination (blood routine, urine routine, stool routine + occult blood, blood biochemistry, blood coagulation routine, thyroid function), complete set of sex hormones, 12-lead electrocardiogram, X-ray (orthotopic), abdominal b-ultrasound (liver, bile, pancreas, spleen and kidney) and clinical significance;
•2. Hepatitis b surface antigen, e antigen, hepatitis c antibody, HIV antibody and syphilis antibody, any one of these is positive.
•3. Any medication taken within 14 days prior to screening;
•4. Taking any clinical trial drug or participating in any clinical trial of any drug within 3 months prior to the screening period or preparing to participate in any other clinical trial within 1 month after the end of this trial;
•5. Persons with history of organic heart disease, heart failure, myocardial infarction, angina pectoris, cardiac arrhythmias can not be explained, reverse sexual ventricular tachycardia, ventricular tachycardia, lengthened QT syndrome history or have QT syndrome symptoms and family history;
•6. Persons who underwent major surgery within 6 months before the screening period or the surgical incision was not completely healed;Major surgery includes, but is not limited to, any operation with significant risk of bleeding, prolonged general anesthesia, open biopsy or significant traumatic injury;
•7. A history of any clinical serious illness or disease or condition that the investigator believes may affect the results of the study, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary or blood, immune, mental and metabolic diseases;
•8. Subject with known hypersensitivity or allergy to SHR4640, or any component of SHR4640;
•9. Hemorrhoids or perianal disease with regular/ongoing hematochezia;
•10. Subjects who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease;
+7 more criteria

Locations (1)

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

March 19, 2020

Primary Completion Date

April 3, 2020

Completion Date

April 3, 2020

Last Updated

April 14, 2020

Enrollment

ACTUAL participants

Conditions

Healthy Adult Male Volunteers

Interventions

[14C]SHR4640

DRUG

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Healthy Adult Male Volunteers

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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