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

Healthy Adult Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260373
• Other study ID #: SHR4640-106
• Status: Completed
• Phase: Phase 1
• Start date: March 19, 2020
• Est. completion date: April 3, 2020

Study information

• Verified date: April 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 3, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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;

11. Those who have history of alcohol abuse 1 month prior to screening period, or the alcohol breath test results =20 mg/dl during screening period;

12. Subjects who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study;

13. Subjects who have history of drug abuse or taking soft drug (i.e., marihuana) 3 months prior to screening period or taking hard drugs (i.e., cocaine, amphetamines, benzodiazepine, etc.); or the results of urine test in drugs were positive;

14. Subjects who were used to drink grapefruit juice or overconsumption of tea, coffee, and the drink with caffeine; and cannot give up them during test;

15. Subjects who need long-term exposure to radiation, or who have been exposed to PET-CT or ECT within 3 months prior to study drug administration or who have participated in the labeling test of radiopharmaceuticals;

16. Subjects who have fertility planning within the range of starting trial - 1 year after finishing trial;

17. Subjects who have excessive bleeding or blood donation (400ml) 3 months prior to screening period, or planned to donate blood 1 month after finishing this trial.

Related Conditions & MeSH terms

• Healthy Adult Male Volunteers

Intervention

Drug:
• [14C]SHR4640
Patients will receive single dose of orally [14C]SHR4640 on Day 1.

Locations

Country	Name	City	State
China	First Affiliated Hospital, Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SHR4640 in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body by liquid scintillation counter.	The percentage of radioactive dose of [14C] radiolabelled SHR4640 recovered in urine, faeces and in total, up to Day 10 (approx).	Up to 10 days (approx) from the start of administration.
Primary	Quantitive analysis of the concentrations of SHR4640 in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.	The concentrations of SHR4640 in plasma up to Day 10.	Up to 10 days (approx) from the start of administration.
Primary	Identification of the main metabolite and biotransformation pathway of SHR4640 and investigation of metabolite in plasma by LC-HR MS.	Proportion of different metabolites.	Up to 10 days (approx) from the start of administration.
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events.	Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.	Up to 10 days (approx) from the start of administration.