Ignite Creation Date:
2024-05-05 @ 10:10 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01048203
Status:
COMPLETED
Last Update Posted:
2014-08-27
First Post:
2010-01-08
Brief Title:
A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects
Sponsor:
Active Biotech AB
Organization:
Active Biotech AB
Study Overview
Official Title:
An Open Label Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2014-08
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 is a single site open label single dose non-randomized study in healthy male and female subjects The subjects will be evaluated for plasma urine and feces levels of 14C-ABR-215050 during 21 days
Detailed Description:
As a part of the pharmacokinetic documentation the metabolism and mass balance of 14C-ABR-215050 will be studied in healthy subjects Female healthy subjects are included in the study in case of expanding the indication to female forms of cancer In this study a single dose of 10 mg of the study drug will be administered orally as a solution under fasted conditions The absorption and safety profiles for the oral water solution will also be documented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2008-003163-39 | EUDRACT_NUMBER | None | None |