Human Mass Balance Study of [¹⁴C]HRS-1893
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Wenzheng Xiong
- Phone Number: +86-0518-82342973
- Email: wenzheng.xiong.wx10@hengrui.com
Study Contact Backup
- Name: Jing He
- Phone Number: +86-0518-82342973
- Email: jing.he@hengrui.com
Study Locations
-
-
Jiangsu
-
Wuxi, Jiangsu, China, 214100
- Jiangnan University Affiliated Hospital
-
Contact:
- Yiqing Zhao
- Phone Number: +86-0510-88682779
- Email: 13358100007@126.com
-
Principal Investigator:
- Yiqing Zhao
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age range: 18 - 45 years old (inclusive of the boundaries, based on the date of signing the informed consent form). Healthy male.
- Body Mass Index (BMI) ranging from 19 to 26 kg/m2 (including the boundary values), with a weight of ≥ 50.0 kg.
- After comprehensive physical examinations (including vital signs, physical examinations, etc.) and laboratory tests (such as blood routine, blood biochemistry, coagulation function, urine routine, fecal routine + occult blood, thyroid function), as well as abdominal B-ultrasound and chest anteroposterior X-ray films, no clinically significant abnormalities were found (ALT, AST, total bilirubin, direct bilirubin, creatine kinase must be < 1.5 times the upper limit of the normal reference value, glomerular filtration rate (eGFR) > 90 mL/(min·1.73 m2)), or the researchers judged that there were minor abnormalities that did not affect the participants' enrollment (such as hemangioma, cyst, calcification focus, nodules, etc.). Among them, abdominal B-ultrasound and chest anteroposterior X-ray films can accept the abdominal B-ultrasound or abdominal CT that can be traced within 6 months before administration, and the results of chest anteroposterior X-ray films or chest CT.
- The 12-lead electrocardiogram shows no clinically significant abnormalities (among which QTc Fridericia (QTcF) must be < 450 ms).
- Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.
Exclusion Criteria:
- Systolic blood pressure (SBP) during the screening period or baseline period: SBP ≥ 140 mmHg or < 90 mmHg; Diastolic blood pressure (DBP): DBP ≥ 90 mmHg or < 60 mmHg, and the clinical doctor determines that it has clinical significance.
- During the screening period, any one of the following infectious disease screenings - hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or human immunodeficiency virus antibody - showing any abnormal result and judged by the researcher to have clinical significance will be included.
- There is a history of syncope in the past.
- Those who have a history of allergies to drugs, foods, or the environment, or who are allergic to the test drug or any of its components.
- Within one month prior to taking the research drug, any prescription drugs, over-the-counter drugs, or herbal medicines were taken; those whose drug half-life was within five half-lives at the time of screening; and those who plan to take non-research trial drugs during the trial period.
- Select those who smoked an average of more than 5 cigarettes per day over the past 4 weeks; those who consumed an average of more than 15 grams of alcohol per day in a week (15 grams of alcohol is equivalent to 450 mL of beer or 150 mL of wine or 50 mL of low-alcohol liquor); or those whose alcohol breath test result was greater than 0 mg/100 mL during the screening period; or those who refrained from smoking, drinking alcohol and consuming caffeinated foods or beverages during the screening period and the test period, and had special dietary requirements that they could not comply with the unified diet.
- Habitual constipation or diarrhea.
- Those with a history of drug use or substance abuse; or those who tested positive for drug abuse in the screening urine test during the selection process.
- Those who habitually consume grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages, or those who are unable to quit during the trial period.
- Those who have a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection.
- Screen those who have participated in any clinical trials of drugs or medical devices within the past three months (the definition of participation in clinical trials is based on the participants receiving treatment with the trial drugs or medical devices).
- Those who received the vaccine within the previous 1 month or during the trial period or within 1 month after administration.
- Those who had experienced blood loss or blood donation of 400 mL within the past 3 months, or those who received blood transfusion within the past 1 month will be selected.
- Staff members of the research center or other individuals directly involved in the implementation of the plan.
- The researchers believe that there are other circumstances that make the participants unsuitable for this trial, such as those that might increase the risk of the trial, affect the participants' compliance with the protocol, or cause physical or psychological conditions that prevent them from completing the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: [14C]HRS-1893 Group
[14C]HRS-1893.
|
[14C]HRS-1893 suspension.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total radioactivity ratio of whole blood/plasma
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Time to reach maximum concentration (Tmax)
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Maximum concentration (Cmax)
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Area under the plasma concentration-time curve from Time 0 to the last quantifiable time point (AUC0-t)
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Area under the plasma concentration-time curve from Time 0 to infinity (AUC0-∞)
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Half-life (t1/2)
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Apparent clearance (CL/F)
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Apparent volume of distribution (V/F)
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Total radioactivity ratio for blood/plasma
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs
Time Frame: 0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HRS-1893-107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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