Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT01147718
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2010-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Drug Interaction Study of Albiglutide and Digoxin
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Digoxin When Coadministered With Albiglutide in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.
Detailed Description:
This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects. Subjects will receive a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected doses of albiglutide and a second single dose of digoxin on Day 38. To determine the plasma pharmacokinetic parameters of digoxin after drug administration alone and after multiple doses of albiglutide, blood samples will be collected after each dose of digoxin.
Study Oversight
Has Oversight DMC:
True
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?: