Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627231
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Mass Balance Clinical Trial With TEV-56286
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Open-Label Mass Balance Clinical Trial to Investigate the Absorption Metabolism and Excretion of Single Oral Administration of 14C-TEV-56286 Following Multiple Oral Administrations of Nonlabeled TEV-56286 to Healthy Male Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Mass balance clinical trial with TEV-56286
Detailed Description:
Primary objectives
To investigate the mass balance and excretion of TEV-56286 following a single oral dose of 14C-TEV-56286
To assess the pharmacokinetics following a single oral dose of 14C-TEV-56286
Secondary objective
- To evaluate the safety and tolerability of TEV-56286 following once daily multiple oral dose administration
The total duration of the clinical trial for each participant is expected to be approximately 59 days
To investigate the mass balance and excretion of TEV-56286 following a single oral dose of 14C-TEV-56286
To assess the pharmacokinetics following a single oral dose of 14C-TEV-56286
Secondary objective
- To evaluate the safety and tolerability of TEV-56286 following once daily multiple oral dose administration
The total duration of the clinical trial for each participant is expected to be approximately 59 days
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