Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01786876
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2013-02-06
Brief Title:
Adsorption Metabolism and Excretion AME of Single Dose Radiolabeled SPD557 in Volunteers
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 1 Study to Investigate the Absorption Metabolism and Excretion of 14CSPD557 Following a Single Oral Dose in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Phase I study to evaluate the excretion of radioactivity the metabolic profile pharmacokinetics safety and tolerability following a single oral administration of 14C SPD557 in healthy male volunteers aged 18 to 50 years inclusiveThe purpose of this study is to investigate how and how quickly SPD557 or its break down products are excreted by analysing blood faeces and urine samples collected during the study
Detailed Description:
None
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