Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-07 @ 11:11 AM
Study NCT ID:
NCT02595203
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2015-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects
Sponsor:
Debiopharm International SA
Organization:
Study Overview
Official Title:
A Phase I, Two-part, Open-label, Non-randomised Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2016-01
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:
The primary objectives of this study are:
* To determine the mass balance recovery (expired air, urine and faeces) and route and rate of elimination of 14C-Debio 1450.
* To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and faeces.
* To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and Debio 1452 (active moiety) in plasma and urine.
* To determine the mass balance recovery (expired air, urine and faeces) and route and rate of elimination of 14C-Debio 1450.
* To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and faeces.
* To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and Debio 1452 (active moiety) in plasma and urine.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-002604-87 | EUDRACT_NUMBER | None | View |