Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836805
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-01
First Post:
2023-04-19
Brief Title:
A Study of the Absorption Metabolism and Excretion of 14CXZP-3621 in Human
Sponsor:
Xuanzhu Biopharmaceutical Co Ltd
Organization:
Xuanzhu Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 1Single-centerOpen-label Study Investigating the Mass BalancePharmacokinetics and Metabolism of 14CXZP-3621 in Healthy Male Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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:
This non-randomized single group open-label study will investigate the mass balance routes of elimination pharmacokinetics metabolism safety and tolerability of a single oral dose of 14CXZP-3621 in healthy volunteers
Detailed Description:
This open-label radiolabeled single 400-mg dose study in approximately 6 healthy male volunteers has been designed to further the understanding of human metabolism of XZP-3621
Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing D-2 On the morning of Day 1 before dosing subjects will be performed baseline examination and trained on procedures such as medicine-taking PK blood collection urine and fecal collection etc to ensure that the procedures can be performed according to the protocols and standard operating procedures And after an overnight fast of at least 10 h 30 minutes afer a standard meal subjects will receive a single oral dose of 400 mg 200 μCi of 14CXZP-3621 as an oral suspension Water will be banned from 1 hour pre-dose to 1 hour post-dose excluding when taking the medicine and food will be banned within 4 hours post-dose
Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as well as on cumulative urine and feces excreted until Day 14 postdose or until one of the early release criteria is met The early release criteria are 1 recovery in excreta of at least 80 of administered radioactivity or 2 less than 1 of administered radioactivity being recovered in excreta from two consecutive days ie total for urine feces should be 1 on 2 consecutive days
Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing D-2 On the morning of Day 1 before dosing subjects will be performed baseline examination and trained on procedures such as medicine-taking PK blood collection urine and fecal collection etc to ensure that the procedures can be performed according to the protocols and standard operating procedures And after an overnight fast of at least 10 h 30 minutes afer a standard meal subjects will receive a single oral dose of 400 mg 200 μCi of 14CXZP-3621 as an oral suspension Water will be banned from 1 hour pre-dose to 1 hour post-dose excluding when taking the medicine and food will be banned within 4 hours post-dose
Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as well as on cumulative urine and feces excreted until Day 14 postdose or until one of the early release criteria is met The early release criteria are 1 recovery in excreta of at least 80 of administered radioactivity or 2 less than 1 of administered radioactivity being recovered in excreta from two consecutive days ie total for urine feces should be 1 on 2 consecutive days
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?:
None
Is an FDA AA801 Violation?:
None