Overview

Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-

Status:
Terminated
Trial end date:
2017-04-24
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the relative bioavailability of single-dose Simeprevir (SMV), Odalasvir (ODV), and AL-335 when administered as a fixed-dose combination (FDC) compared with the single agents when administered together, and to assess the effect of multiple-dose lansoprazole and omeprazole on the single-dose pharmacokinetics (PK) of SMV, ODV, and AL-335 when administered as an FDC.
Phase:
Phase 1
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Dexlansoprazole
Lansoprazole
Odalasvir
Omeprazole
Simeprevir