Study to Evaluate the Mass Babance and Biotransformation of [14C]SHR6390 in Healthy Adult Male Volunteers

NCT04616742 | Completed Phase 1

• 1 other identifier: SHR6390-I-108
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Evaluate the mass balance and biotransformation of single dose \[14C\]SHR6390 in Chinese healthy adult male volunteers.

Conditions

Healthy Adult Male Volunteers

Outcome Measures

Primary Outcomes (3)

• Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SHR6390 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 SHR6390 recovered in urine,faces and in total,up to Day 21(approx)

  up to Day 21 (approx) from the start of administration.

• Quantitive analysisi of the concentrations of SHR6390 in plasma using the validated LC-MS to obtain pharmacokinetic data.

  The concentration of SHR6390 in plasma up to D7

  up to 7 days (approx) form the start of administration

• Identification of the main metabolite and biotransformation pathway of SHR6390 and investigation of metabolite in plasma by LC-HR MS

  Proportion of different metabolites of SHR6390 up to D7

  up to 7 days (approx) form the start of administration

Secondary Outcomes (1)

• Number of Participants with Adverse Evevts(AEs) and Serious Adverse Evevts

  up to Day 21 (approx) from the start of administration.

Study Arms (1)

[14C]SHR6390

EXPERIMENTAL

Drug: [14C]SHR6390

Interventions

[14C]SHR6390 DRUG

Patients will receive single dose of orally \[14C\]SHR6390 on Day 1.

[14C]SHR6390

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Candidates who meet any of the following conditions will not be selected:
• Laboratory examination:
• Complete physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function, fecal occulted blood, thyroid function (FT3, FT4, TSH), 12-lead electrocardiogram, X-chest X-ray (orthostatic position), abdominal B-ultrasound (liver, bile, pancreas, spleen, kidney) and other abnormal and clinically significant examinations;
• Ophthalmologic examination (slit lamp, intraocular pressure and fundus photography) with abnormal clinical significance;
• Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive.
• Medical history:
• Screening for use of any clinical trial drug within the first 3 months or withdrawal time shorter than the 6 half-life period of the trial drug at enrollment, whichever is the longest of the two;
• CYP3A4, CYP2C8 and CYP2C9 inducers or inhibitors were taken within 28 days before screening, as shown in Appendix 1.
• Use of any prescription or over-the-counter drug, any vitamin product, health care drug or Chinese herbal medicine within 14 days prior to screening;
• Medical history and treatment history:
• clinical symptoms or diseases of the heart that cannot be well controlled, such as :(1) heart failure of NYHA2 or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) supraventral or ventricular arrhythmia with clinical significance that requires treatment or intervention; (5) QTcF\>450ms(male) at screening stage; (5) QTcF\>450ms.
• Patients who had undergone major surgery or whose surgical incision was not completely healed within 6 months before the screening period;Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury;
• Screening for abdominal fistula, gastrointestinal perforation or abdominal abscess in the first 6 months;
• Screening for clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding and bleeding ulcer, in the first 3 months;
• Hemorrhoids or perianal diseases with regular/bleeding in the stool;Patients with gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel disease, may be affected by drug absorption as determined by researchers;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

First affiliated hospital,Soochow University

Suzhou, Jiangsu, 215006, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 5, 2020
• Study Start: November 11, 2020
• Primary Completion: January 8, 2021
• Study Completion: May 1, 2021
• Last Updated: May 12, 2021

Record last verified: 2020-11

Locations

CN (1)