Ignite Creation Date:
2024-05-05 @ 9:38 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00930631
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2009-06-24
Brief Title:
Study of 3H BMS747158 in Healthy Male Subjects
Sponsor:
Lantheus Medical Imaging
Organization:
Lantheus Medical Imaging
Study Overview
Official Title:
Pharmacokinetics Metabolism and Elimination of Tritiated 3H BMS747158 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2011-10
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:
PPA103
Brief Summary:
The purpose of this clinical study is to assess the safety extent and route of 3H BMS747158 radioactivity eliminated mass balance in urine and feces of healthy male subjects The safety of 3H BMS747158 administration will also be assessed as well as pharmacokinetics of 3H BMS747158 and metabolite identification
Detailed Description:
This Phase I nonrandomized open-label study will enroll up to seven healthy male subjects who meet all of the inclusion and none of the exclusion criteria Subjects will receive 100 20 μCi of 3H BMS747158 Subjects will undergo blood urine and fecal collections to evaluate 3H activity for a minimum of 7 days post-dose Safety will be assessed by monitoring of adverse events AEs vital signs physical examinations clinical laboratory tests and electrocardiograms ECGsThis Phase I nonrandomized open-label study will enroll up to seven healthy male subjects who meet all of the inclusion and none of the exclusion criteria Subjects will receive 100 20 μCi of 3H BMS747158 Subjects will undergo blood urine and fecal collections to evaluate 3H activity for a minimum of 7 days post-dose Safety will be assessed by monitoring of adverse events AEs vital signs physical examinations clinical laboratory tests and electrocardiograms ECGs
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