Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186583
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2023-11-20
Brief Title:
A Mass Balance Study of 14CABSK021
Sponsor:
Abbisko Therapeutics Co Ltd
Organization:
Abbisko Therapeutics Co Ltd
Study Overview
Official Title:
A Mass Balance Study of 14CABSK021 in Healthy Adult Male Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2023-11
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 is a single-site open-label single-cohort single-dose study to assess the absorption metabolism and excretion profile of 14C ABSK021 in healthy adult male subjects The study plans to enroll 6 to 10 healthy male subjects to ensure at least 6 evaluable subjects
Detailed Description:
Subjects will be screened within 14 days before dose administration D-14 to D-3 and will be admitted to the trial ward two days before dose administration D-2
On Day 1 subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of 14C ABSK021 in the fasted state
All excreted urine and feces samples and blood samples at specified time points during 0-504 hours after dosing will be collected Random feces within 48 hours prior to dosing and random urine within 24 hours prior to dosing will be collected as blank samples if there are multiple blank samples the most recent blank sample before dosing will be selected for analysis
On Day 1 subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of 14C ABSK021 in the fasted state
All excreted urine and feces samples and blood samples at specified time points during 0-504 hours after dosing will be collected Random feces within 48 hours prior to dosing and random urine within 24 hours prior to dosing will be collected as blank samples if there are multiple blank samples the most recent blank sample before dosing will be selected for analysis
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