Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233916
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2023-11-27
Brief Title:
Mass Balance Study of 14C D-1553 in Chinese Healthy Adult Male Subjects
Sponsor:
InventisBio Co Ltd
Organization:
InventisBio Co Ltd
Study Overview
Official Title:
Mass Balance Study of 14C D-1553 in Chinese Healthy Adult Male Subjects
Status:
COMPLETED
Status Verified Date:
2024-01
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:
To quantitatively analyze the total radioactivity TRA in excrement after a single oral dose of 14C D-1553 in healthy subjects and obtain radioactivity recovery and primary excretion pathways in humans
To obtain radioactive metabolite profiles of human plasma urine and feces identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways
To quantitatively analyze the TRA in whole blood and plasma and obtain PK parameters of plasma TRA and investigate whole bloodplasma ratio for TRA
To obtain radioactive metabolite profiles of human plasma urine and feces identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways
To quantitatively analyze the TRA in whole blood and plasma and obtain PK parameters of plasma TRA and investigate whole bloodplasma ratio for TRA
Detailed Description:
Primary Objectives
To quantitatively analyze the total radioactivity TRA in excrement after a single oral dose of 14C D-1553 in healthy subjects and obtain radioactivity recovery and primary excretion pathways in humans
To obtain radioactive metabolite profiles of human plasma urine and feces after a single oral dose of 14C D-1553 in healthy subjects identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways
To quantitatively analyze the TRA in whole blood and plasma after a single oral dose of 14C D-1553 in subjects and obtain PK parameters of plasma TRA and investigate whole bloodplasma ratio for TRA
Secondary Objectives
To observe the safety of a single oral dose of 14C D-1553 in healthy subjects
To quantitatively analyze the concentration of D-1553 and its metabolites if applicable in plasma using the validated LC-MS liquid chromatography-mass spectrometryMS method and obtain the pharmacokinetic PK parameters of D-1553 and its metabolites if applicable in plasma
To quantitatively analyze the total radioactivity TRA in excrement after a single oral dose of 14C D-1553 in healthy subjects and obtain radioactivity recovery and primary excretion pathways in humans
To obtain radioactive metabolite profiles of human plasma urine and feces after a single oral dose of 14C D-1553 in healthy subjects identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways
To quantitatively analyze the TRA in whole blood and plasma after a single oral dose of 14C D-1553 in subjects and obtain PK parameters of plasma TRA and investigate whole bloodplasma ratio for TRA
Secondary Objectives
To observe the safety of a single oral dose of 14C D-1553 in healthy subjects
To quantitatively analyze the concentration of D-1553 and its metabolites if applicable in plasma using the validated LC-MS liquid chromatography-mass spectrometryMS method and obtain the pharmacokinetic PK parameters of D-1553 and its metabolites if applicable in plasma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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