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A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

NCT02421211 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-03-28

Study results available
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Summary

The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Simeprevir (SMV)

Participants will receive 150 milligram (mg) of SMV (Treatment A) once daily in Panel 1 and Panel 2.

DRUG

Ledipasvir (LDV)

Participants will receive 90 mg of LDV once daily as FDC tablet with SOF (Treatment B) in Panel 1 and Panel 2.

DRUG

Sofosbuvir (SOF)

Participants will receive 400 mg of SOF alone (Treatment C) in Panel 1 and as FDC tablet with LDV (Treatment B) once daily in Panel 2.

Sponsors & Collaborators

  • Janssen Sciences Ireland UC

    lead INDUSTRY

Principal Investigators

  • Janssen Sciences Ireland UC Clinical Trial · Janssen Sciences Ireland UC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-19
Primary Completion
2015-11-10
Completion
2016-01-27

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421211 on ClinicalTrials.gov