Back to resultsThe Mass Balance Study of [14C]JT001
Primary Purpose
Healthy Subjects
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
[14C]JT001
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Subjects
Eligibility Criteria
Inclusion Criteria: Healthy adult males Age: 18-45 years old Body weight: Body mass index (BMI) is between 19.0 and 26.0 kg/m2 (including boundary values), and the body weight of the subject is not less than 50.0 kg; Voluntarily sign informed consent; Subjects were able to complete the trail according to protocol. Exclusion Criteria: Physical examination, vital signs, routine laboratory examination, imaging examination abnormal and clinically significant The electrocardiogram was abnormal and was considered clinically significant by the investigators, or has a history of organic heart disease Has hepatitis B (HBV) or hepatitis C (HCV) or HIV antibody and syphilis antibody positive; Any drug that inhibits or induces the drug transporters P-gp and BCRP has been used within 30 days prior to the screening period Any conditions that may affect drug absorption. Previous antineoplastic therapy meets washout requirements. Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease Habitual constipation or diarrhea. Significant radioactive exposure within 1 year.
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[14C]JT001
Arm Description
Outcomes
Primary Outcome Measures
Total radioactive recovery
The percentage of radioactivity recovered from collected samples
cumulative excretion rate of total radioactive material in fecal matter
After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces
Peak concentration（Cmax）
The highest plasma drug concentration that can be achieved after medication
time to peak（Tmax）
After a single dose, the time of peak blood concentration
elimination half life（t1/2）
the time it takes the blood to reduce the concentration of the drug to half
Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS)
The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS)
Secondary Outcome Measures
Adverse events (AEs)
Number of cases and incidence of adverse events(AEs)
Full Information
NCT ID
NCT05802810
First Posted
February 17, 2023
Last Updated
April 4, 2023
Sponsor
Shanghai Vinnerna Biosciences Co., Ltd.
Collaborators
Sponsor GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05802810
Brief Title
The Mass Balance Study of [14C]JT001
Official Title
The Mass Balance Study of [14C]JT001 in Chinese Healthy Adult Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Vinnerna Biosciences Co., Ltd.
Collaborators
Sponsor GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a single center, single dose, non-randomized, open design clinical study.By quantitative analysis of the biological samples of subjects after oral administration of [14C]JT001, the data of human radioactive excretion rate and the main excretion pathway will be obtained. The main metabolites ,metabolic pathways and elimination pathways of JT001 will be identified.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single Group
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[14C]JT001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[14C]JT001
Intervention Description
Subjects will receive approximately 300 mg/100 µCi of [14C]JT001 orally.
Primary Outcome Measure Information:
Title
Total radioactive recovery
Description
The percentage of radioactivity recovered from collected samples
Time Frame
1 month
Title
cumulative excretion rate of total radioactive material in fecal matter
Description
After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces
Time Frame
1 month
Title
Peak concentration（Cmax）
Description
The highest plasma drug concentration that can be achieved after medication
Time Frame
1 month
Title
time to peak（Tmax）
Description
After a single dose, the time of peak blood concentration
Time Frame
1 month
Title
elimination half life（t1/2）
Description
the time it takes the blood to reduce the concentration of the drug to half
Time Frame
1 month
Title
Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS)
Description
The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Adverse events (AEs)
Description
Number of cases and incidence of adverse events(AEs)
Time Frame
2 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult males
Age: 18-45 years old
Body weight: Body mass index (BMI) is between 19.0 and 26.0 kg/m2 (including boundary values), and the body weight of the subject is not less than 50.0 kg;
Voluntarily sign informed consent;
Subjects were able to complete the trail according to protocol.
Exclusion Criteria:
Physical examination, vital signs, routine laboratory examination, imaging examination abnormal and clinically significant
The electrocardiogram was abnormal and was considered clinically significant by the investigators, or has a history of organic heart disease
Has hepatitis B (HBV) or hepatitis C (HCV) or HIV antibody and syphilis antibody positive;
Any drug that inhibits or induces the drug transporters P-gp and BCRP has been used within 30 days prior to the screening period
Any conditions that may affect drug absorption.
Previous antineoplastic therapy meets washout requirements.
Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease
Habitual constipation or diarrhea.
Significant radioactive exposure within 1 year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Xu, Project manager
Phone
+86 13761020175
Email
kai_xu@junshipharma.com
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liyan Miao, Ph.D
Phone
86 0512-67972858
Email
miaolysyzhou@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Mass Balance Study of [14C]JT001
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