Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01353716
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2011-05-12
Brief Title:
Dolutegravir Renal Impairment Study
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Phase I Open-Label Parallel-Group Study to Evaluate the Pharmacokinetics and Safety of Dolutegravir in Subjects With Renal Impairment and Healthy Matched Control Subjects ING113125
Status:
COMPLETED
Status Verified Date:
2012-04
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:
Dolutegravir DTG 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 DTG is metabolized primarily by uridine diphosphate glucuronyltransferase UGT1A1 with a minor role of cytochrome P450 CYP3A and with renal elimination of unchanged drug being extremely low 1 of the dose Fifty-three percent of the total oral dose is excreted unchanged in the feces but it is unknown if all or part of this is due to unabsorbed drug or some percentage of biliary excretion of the glucuronide conjugate which can be further degraded to form the parent compound in the gut lumen The current Food and Drug Administration FDA draft guidance for renal impairment studies states that a pharmacokinetic PK study in patients with renal impairment should be conducted even for those drugs primarily metabolized or secreted in bile because renal impairment can inhibit some pathways of hepatic and gut drug metabolism and transport
This study is planned as an open label single-dose pharmacokinetic study to evaluate plasma DTG pharmacokinetics following oral administration to subjects with severe renal impairment creatinine clearance 30 mlmin and matched healthy controls Results from this study are expected to enable the development of appropriate dosing recommendations in patients with renal impairment
This study is planned as an open label single-dose pharmacokinetic study to evaluate plasma DTG pharmacokinetics following oral administration to subjects with severe renal impairment creatinine clearance 30 mlmin and matched healthy controls Results from this study are expected to enable the development of appropriate dosing recommendations in patients with renal impairment
Detailed Description:
ViiV Healthcare is the new sponsor of this study and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
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