Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04540016
Status:
COMPLETED
Last Update Posted:
2022-12-12
First Post:
2020-08-25
Brief Title:
Mass Balance and Biotransformation of 14CHSK7653 in Human
Sponsor:
Sichuan Haisco Pharmaceutical Group Co Ltd
Organization:
Haisco Pharmaceutical Group Co Ltd
Study Overview
Official Title:
A Clinical Trial on Absorption Metabolism and Excretion of 14CHSK7653 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of 14CHSK7653 in Human
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single-center single-dose non-randomized open-label design
Detailed Description:
Six healthy adult male subjects will be enrolled and the trial will be carried out in two steps
Step 1 Two eligible male subjects are enrolled and admitted to the clinical study site after passing verification against inclusion and exclusion criteria on Day -2 After being admitted the subjects are trained regarding drug administration and urine and stool collection procedures to ensure that they are able to perform relevant operations according to the protocol and SOP requirements Subjects are deprived of food for at least 10 h and of water for 1 h before drug administration After oral administration of investigational product in the morning of Day 1 under fasted condition each subject will be deprived of food for 4 h and of water for 1 h
Dense sampling is scheduled for all urine and stool samples excreted at specified time intervals within 0-336 h post-dose as well as blood samples at specified time points within 0-336 h post-dose Sample collection and corresponding safety monitoring will be completed in the morning of Day 15 the specific time will be decided by the investigator and sponsor based on the phased test results safety results and the actual situation before the subjects leave the phase I clinical trial ward Subjects will return to the ward on Days 19 26 33 and 40 to complete biological sample collection and vital sign monitoring according to protocol requirements Subjects will return to the ward on Day 47 to complete the last biological sample collection scheduled to be 1176 h after administration and various withdrawal examinations according to protocol requirements
The trial employs phased testing to determine whether the dense sampling and sparse sampling time points should be adjusted and whether collection of blood urine and stool samples can be prematurely stopped or should be continued for an extended period based on the test results If biological sampling duration exceeds 1176 h in this study then sampling will continue at an interval of 7 days until the protocol-specified evaluation criteria for sampling termination is satisfied Safety monitoring will continue until the date of sampling completion The test results in step 1 will be used to determine whether the trial procedure needs to be adjusted
Step 2 Four eligible male subjects will be enrolled and blood urine and stool samples will be collected at specified time pointsintervals The procedures are the same as step 1
Criteria for sampling termination
Excretion The radioactivity of biological samples urine stool collected over two consecutive time intervals from the subject is less than 1 of the dose
Radioactive blood samples Plasma radioactivity concentrations at two consecutive time points are 3 times background plasma concentration
The target total radioactivity of biological samples urine stool collected from each subject is not lower than 80 of the dose The investigator should finally determine whether to stop sampling of a subject based on the comprehensive evaluation of radioactive test results safety results and the actual situation
The entire trial is based on the complete test samples and data collected from 6 subjects All subjects must complete the trial procedures according to the protocol requirements during admission in the clinical study site and they are not allowed to leave the clinical study site without permission by the investigator
Subject may withdraw from the study upon confirmation by the investigator provided that no clinically significant abnormality is observed in clinical observation after completion of the trial Should any clinically significant abnormality be found the subject will continue to stay at the study site for observation or leave the study site after comprehensive assessment by the investigator and periodically usually 7 days from the last test return to the hospital for retests and followed up until recovery to normal the abnormality is not clinically significant or a level deemed acceptable by the investigator
Step 1 Two eligible male subjects are enrolled and admitted to the clinical study site after passing verification against inclusion and exclusion criteria on Day -2 After being admitted the subjects are trained regarding drug administration and urine and stool collection procedures to ensure that they are able to perform relevant operations according to the protocol and SOP requirements Subjects are deprived of food for at least 10 h and of water for 1 h before drug administration After oral administration of investigational product in the morning of Day 1 under fasted condition each subject will be deprived of food for 4 h and of water for 1 h
Dense sampling is scheduled for all urine and stool samples excreted at specified time intervals within 0-336 h post-dose as well as blood samples at specified time points within 0-336 h post-dose Sample collection and corresponding safety monitoring will be completed in the morning of Day 15 the specific time will be decided by the investigator and sponsor based on the phased test results safety results and the actual situation before the subjects leave the phase I clinical trial ward Subjects will return to the ward on Days 19 26 33 and 40 to complete biological sample collection and vital sign monitoring according to protocol requirements Subjects will return to the ward on Day 47 to complete the last biological sample collection scheduled to be 1176 h after administration and various withdrawal examinations according to protocol requirements
The trial employs phased testing to determine whether the dense sampling and sparse sampling time points should be adjusted and whether collection of blood urine and stool samples can be prematurely stopped or should be continued for an extended period based on the test results If biological sampling duration exceeds 1176 h in this study then sampling will continue at an interval of 7 days until the protocol-specified evaluation criteria for sampling termination is satisfied Safety monitoring will continue until the date of sampling completion The test results in step 1 will be used to determine whether the trial procedure needs to be adjusted
Step 2 Four eligible male subjects will be enrolled and blood urine and stool samples will be collected at specified time pointsintervals The procedures are the same as step 1
Criteria for sampling termination
Excretion The radioactivity of biological samples urine stool collected over two consecutive time intervals from the subject is less than 1 of the dose
Radioactive blood samples Plasma radioactivity concentrations at two consecutive time points are 3 times background plasma concentration
The target total radioactivity of biological samples urine stool collected from each subject is not lower than 80 of the dose The investigator should finally determine whether to stop sampling of a subject based on the comprehensive evaluation of radioactive test results safety results and the actual situation
The entire trial is based on the complete test samples and data collected from 6 subjects All subjects must complete the trial procedures according to the protocol requirements during admission in the clinical study site and they are not allowed to leave the clinical study site without permission by the investigator
Subject may withdraw from the study upon confirmation by the investigator provided that no clinically significant abnormality is observed in clinical observation after completion of the trial Should any clinically significant abnormality be found the subject will continue to stay at the study site for observation or leave the study site after comprehensive assessment by the investigator and periodically usually 7 days from the last test return to the hospital for retests and followed up until recovery to normal the abnormality is not clinically significant or a level deemed acceptable by the investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None