Study to Evaluate the Mass Balance and Biotransformation of [14C]SHR1459 in Healthy Adult Male Volunteers

NCT05095337 | Unknown Phase 1

• 1 other identifier: SHR1459-I-108
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the Mass Balance and Biotransformation of \[14C\]SHR1459 in Healthy Adult Male Volunteers

Conditions

Healthy Adult Male Volunteers

Outcome Measures

Primary Outcomes (10)

• Tmax

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

• Cmax

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

• AUC0-t

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

• AUC0-∞

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

• t1/2

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

• CL/F

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

• Vz/F

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

• Total radioactivity ratio for blood/plasma

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

• cumulative recovery of total radioactive substances in urine and/or feces;

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

• Percentage of metabolites in urine and feces in dose administration (% of dose administration) or percentage of circulating metabolites in plasma in total exposure AUC (%AUC);

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

Secondary Outcomes (1)

• Number of Participants with Adverse Events(AEs) and Serious Adverse Events.

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

Study Arms (1)

[14C]SHR1459

EXPERIMENTAL

Drug: [14C]SHR1459

Interventions

[14C]SHR1459 DRUG

Patients will receive single dose of orally \[14C\]SHR1459 on Day 1.

[14C]SHR1459

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 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)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 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: March 1, 2021
• First Posted: October 27, 2021
• Study Start: June 7, 2022
• Primary Completion: July 5, 2022
• Study Completion: July 25, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

CN (1)