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.

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult Male Volunteers
• Intervention / Treatment: Drug: [14C]SHR4640

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • First Affiliated Hospital, SooChow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]SHR4640; Patients will receive single dose of [14C]SHR4640 (Suspension, 10mg/80μCi).	Drug: [14C]SHR4640; Patients will receive single dose of orally [14C]SHR4640 on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2020
• Primary Completion (Actual): April 3, 2020
• Study Completion (Actual): April 3, 2020

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SHR4640-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No