Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT01214993
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2010-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects
Sponsor:
ViiV Healthcare
Organization:
Study Overview
Official Title:
A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2012-06
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:
The current study is designed to confirm the mechanism behind the increase in serum creatinine observed during GSK1349572 therapy; specifically, the study will determine whether GSK1349572 has any effect on glomerular filtration rate (GFR) or effective renal plasma flow. Absent such effects, one may conclude that the small increases in serum creatinine observed are due to the inhibition of the tubular secretion of creatinine via organic cation transporter 2 (OCT2) consistent with in vitro data. .
Detailed Description:
GSK1349572 is an integrase inhibitor being developed for the treatment of human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV Healthcare LLC. In healthy subjects and in dose-ranging clinical trials of GSK1349572, subjects showed a small, reversible increase in serum creatinine concentrations as compared to the control groups; this occurred early during study drug administration and did not progress over time. In vitro data demonstrate that GSK1349572 inhibits the organic cation transporter (OCT2), which mediates the tubular secretion of creatinine; drugs such as cimetidine with similar effects on OCT2 lead to a nonpathological increase in creatinine with no effect on glomerular filtration rate (GFR). The current study is designed to confirm the mechanism behind the increase in serum creatinine observed during GSK1349572 therapy; specifically, the study will determine whether GSK1349572 has any effect on GFR or effective renal plasma flow. Absent such effects, one may conclude that the small increases in serum creatinine observed are due to the inhibition of the tubular secretion of creatinine via OCT2.
Subjects will be given GSK1349572 50mg once daily, 50mg twice daily or placebo once daily for 14 days. Changes in the subject's GFR will be measured through administration of iohexol and effective renal plasma flow will be measured using Para-Aminohippurate (PAH) on days -1, 7 and 14. Changes in serum creatinine and other renal biomarkers will be evaluated at baseline and at various time points throughout the study.
Subjects will be given GSK1349572 50mg once daily, 50mg twice daily or placebo once daily for 14 days. Changes in the subject's GFR will be measured through administration of iohexol and effective renal plasma flow will be measured using Para-Aminohippurate (PAH) on days -1, 7 and 14. Changes in serum creatinine and other renal biomarkers will be evaluated at baseline and at various time points throughout the study.
Study Oversight
Has Oversight DMC:
False
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?: