This study aims to provide clinical information on a potential drug-drug interaction between daclatasvir and metformin.
Daclatasvir is a recently approved anti-HCV agent that is a cytochrome P450 3a (CYP3A) substrate but does not affect CYP3A itself. It is also a moderate inhibitor of various membrane transporters such as organic anion-transporting polypeptide 1B1 (OATP1B1) , p-glycoprotein (P-gP), and organic cation transporter (OCT) 1 and 2. Metformin is used to treat diabetes mellitus. It is an OCT-2 and OCT-1 substrate and when combined with daclatasvir increased levels of metformin may occur, with risk on hypoglycaemic episodes. The Summary of Product Characteristics (SmPC) of daclatasvir currently does not mention this potential drug-drug interaction. HCV is associated with insulin resistance (IR) which may develop to diabetes mellitus (DM). The prevalence of IR in HCV infected patients is estimated varying from 30% to 70%. Several studies showed that IR has a negative impact on the achievement of an undetectable HCV viral load after completing 12 weeks of treatment (Sustained Virologic Response (SVR)). This study aims to provide clinical information on a potential drug-drug interaction between daclatasvir and metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
CRCN, Radboud University Medical Center
Nijmegen, Netherlands
Area Under the Curve (AUC)
Time frame: up to 24 hours after administration for daclatasvir and up to 12 hours after administration for metformin
adverse events
adverse events will be collected up to 4 weeks in total (entire study)
Time frame: 4 weeks
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