A Drug-drug Interaction Study Between Daclatasvir and Metformin (DATE-3)
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|ClinicalTrials.gov Identifier: NCT02565862|
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : April 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Diabetes Mellitus Insulin Resistance||Drug: Daclatasvir Drug: Metformin||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Drug-drug Interaction Study Between the Novel Anti-hepatitis c Virus (HCV) Agent Daclatasvir and The Antidiabetic Agent Metformin in Healthy Volunteers|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 2016|
Active Comparator: Treatment A
Day 1-2: 500mg twice daily (BID) metformin film-coated tablets
Day 3-8: 1000mg BID metformin film-coated tablets
Experimental: Treatment B
Day 15-16: 500mg BID metformin film-coated tablets + 60mg once daily (QD) daclatasvir film-coated tablets
Day 17-22: 1000mg BID metformin film-coated tablets
+ 60mg QD daclatasvir film-coated tablets
Other Name: Daklinza
- 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 [ Time Frame: 4 weeks ]adverse events will be collected up to 4 weeks in total (entire study)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565862
|CRCN, Radboud University Medical Center|
|Principal Investigator:||David Burger, PharmD, PhD||Radboud University|