NCT02421211View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

May 19, 2015

Primary Completion Date

November 10, 2015

Study Completion Date

January 27, 2016

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.

Trial Locations (4)

Unknown

Antwerp

Brussels

Ghent

Leuven

All Listed Sponsors
lead

Janssen Sciences Ireland UC

INDUSTRY

NCT02421211 - 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 | Biotech Hunter | Biotech Hunter