EIG-LMD-004 DDI Study
Research type
Research Study
Full title
A Phase 1, open-label, single-sequence, cocktail drug-drug interaction study evaluating the effect of multiple-dose Lambda on the single-dose pharmacokinetics of the preferred CYP enzyme substrates and a preferred OATP1B1/OATP1B3 substrate administered to patients with chronic HDV infection.
IRAS ID
1006719
Contact name
Isabel Valentin Verdeguer
Contact email
Sponsor organisation
Eiger BioPharmaceuticals, Inc.
Eudract number
2022-001276-34
Research summary
This study is being conducted to learn more about peginterferon lambda-1a (Lambda) and how it may help to treat patients who are living with chronic HDV infection. The goal of this study is to understand whether Lambda interacts with certain types of commonly prescribed medication classes when they are taken at the same time. If there is an interaction, this could result in either drug (Lambda and/or the other drug being taken) becoming more effective or less effective than when the drug (Lambda and/or the other drug) is taken alone. An interaction between these drugs could also affect the side effect profile of one or both drugs, meaning you could have a greater chance of having a side effect or you could have a side effect that you would not otherwise experience when taking either drug alone.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0863
Date of REC Opinion
2 May 2023
REC opinion
Further Information Favourable Opinion