Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-07 @ 12:47 AM
Study NCT ID:
NCT02172157
Status:
COMPLETED
Last Update Posted:
2014-06-24
First Post:
2014-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Metabolism and Pharmacokinetics of [14C]BI 1744 CL and [14C]BI 1744 CL Administered as an Oral Solution in Healthy Male Subjects
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Investigation of the Metabolism and Pharmacokinetics of 20 μg (Calculated as Free Base) [14C]BI 1744 CL Administered as a 3-hour Infusion and 40 μg (Calculated as Free Base) [14C]BI 1744 CL Administered as an Oral Solution.
Status:
COMPLETED
Status Verified Date:
2014-06
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:
Primary objective:
To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS - glucuronide and \[14C\]-radioactivity including excretion mass balance, excretion pathways and metabolism following intravenous and oral administration of \[14C\]BI 1744 CL
Secondary objective:
To determine safety and tolerability following intravenous and oral administration of \[14C\]BI 1744 CL in healthy male subjects
To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS - glucuronide and \[14C\]-radioactivity including excretion mass balance, excretion pathways and metabolism following intravenous and oral administration of \[14C\]BI 1744 CL
Secondary objective:
To determine safety and tolerability following intravenous and oral administration of \[14C\]BI 1744 CL in healthy male subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: