Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-03 @ 10:37 PM
Study NCT ID:
NCT05200169
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
Sponsor:
AB Science
Organization:
Study Overview
Official Title:
An Open-Label, Non-Randomised, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2022-01
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 assess the mass balance recovery after a single oral dose of 14C-AB1010
Detailed Description:
The objective is to characterize the distribution, metabolism and elimination of AB1010 in humans through the sampling of blood, urine, and faeces. This is accomplished through the administration of 14C-AB1010 oral solution with a therapeutic relevant dose of AB1010 as a single oral dose. There was no control group and no blinding as the objective was to assess the mass balance of masitinib after a single oral intake. There was only one group of healthy male volunteers.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-001948-34 | EUDRACT_NUMBER | None | View |