Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05489744
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2022-07-12
Brief Title:
Human Mass Balance and Biotransformation Study of 14CAfuresertib
Sponsor:
Laekna Limited
Organization:
Laekna Limited
Study Overview
Official Title:
In Vivo Absorption Metabolism Excretion AME Clinical Study of 14CAfuresertib in Healthy Chinese Male Adults - Human Mass Balance and Biotransformation Study of 14CAfuresertib
Status:
COMPLETED
Status Verified Date:
2023-05
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 study adopts a single-center single-dose non-randomized open-label design with a proposed enrollment of 6-10 healthy male subjects After a single oral dose of approximately 125 mg150 µCi 14CAfuresertib tablets blood urine and fecal specimens are collected from each subject at defined time pointsperiods during the trial and PK parameters recovery and excretion routes of 14CAfuresertib in plasma are calculated by measuring the total radioactivity The main metabolic and elimination pathways and characteristics of Afuresertib in human as well as circulating metabolites with close to or higher than 10 of plasma total radioactivity exposure are also identified by plasma urine and fecal radioactive metabolite profiles and major metabolite structure
Detailed Description:
This study includes two stages
Stage I The subjects are subject to the screening examination from D-7 to D-2 Two healthy adult male subjects selected from those who pass the examination are admitted to the clinical research center after qualification against the inclusion and exclusion criteria on D-2 and receive the baseline examination on D-1 After admission they are trained on medication urine and feces collection and other procedures to ensure that they can perform related operations in accordance with the protocol and operating manual for biospecimen analysis for mass balance and biotransformation study Random urine and feces specimens -24 h to 0 h are collected on D-1 and the subjects are deprived of food for at least 10 h and water for 1 h before dosing On the morning of the first day of the study blood specimens are collected within 1 h before dosing and the investigational product is taken orally on an empty stomach with 240 mL of warm water The subjects are deprived of food for 4 h and water for 1 h after dosing All urine and feces specimens excreted within the specified time intervals of 0-504 h and blood specimens sampled at specified time points before and within 0-504 h after dosing are collected Phased testing is adopted in this study to determine whether specimen collection may be terminated in advance or the collection time needs to be prolonged based on the test results If the specimen collection time exceeds 504 h the collection should be extended at an interval of 24 h urine feces or an integer multiple interval of 24 h plasma until the criteria for termination of specimen collection specified in the protocol are met Meanwhile the safety monitoring is continued until the completion date of the specimen collection
Stage II According to the results of the Stage I study the necessarily for plan adjustment dosing regimen biospecimen collection etc is evaluated and another 4-8 subjects will be selected if necessary
Stage I The subjects are subject to the screening examination from D-7 to D-2 Two healthy adult male subjects selected from those who pass the examination are admitted to the clinical research center after qualification against the inclusion and exclusion criteria on D-2 and receive the baseline examination on D-1 After admission they are trained on medication urine and feces collection and other procedures to ensure that they can perform related operations in accordance with the protocol and operating manual for biospecimen analysis for mass balance and biotransformation study Random urine and feces specimens -24 h to 0 h are collected on D-1 and the subjects are deprived of food for at least 10 h and water for 1 h before dosing On the morning of the first day of the study blood specimens are collected within 1 h before dosing and the investigational product is taken orally on an empty stomach with 240 mL of warm water The subjects are deprived of food for 4 h and water for 1 h after dosing All urine and feces specimens excreted within the specified time intervals of 0-504 h and blood specimens sampled at specified time points before and within 0-504 h after dosing are collected Phased testing is adopted in this study to determine whether specimen collection may be terminated in advance or the collection time needs to be prolonged based on the test results If the specimen collection time exceeds 504 h the collection should be extended at an interval of 24 h urine feces or an integer multiple interval of 24 h plasma until the criteria for termination of specimen collection specified in the protocol are met Meanwhile the safety monitoring is continued until the completion date of the specimen collection
Stage II According to the results of the Stage I study the necessarily for plan adjustment dosing regimen biospecimen collection etc is evaluated and another 4-8 subjects will be selected if necessary
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