Infection, Human Immunodeficiency Virus Clinical Trial
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)
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 (UGT)1A1, with a minor role of cytochrome P450 (CYP)3A, 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current Food and Drug Administration (FDA) draft guidance for renal impairment studies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 ml/min) and matched healthy controls. Results from
this study are expected to enable the development of appropriate dosing recommendations in
patients with renal impairment.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship. ;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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