Trials Sponsors Conditions Drugs Pricing

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]SHR1459Drug

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

[14C]SHR1459

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Signing the informed consent forms;
Healthy adult males;

Sponsors & Collaborators

Jiangsu HengRui Medicine Co., Ltd.
Industrylead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Enrollment

6 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

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;
+11 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (10)

Secondary Outcomes (1)

Study Arms (1)

[14C]SHR1459

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (10)

Secondary Outcomes (1)

Study Arms (1)

[14C]SHR1459

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations