Simeprevir (SMV)
Sponsors
Janssen Sciences Ireland UC, Alios Biopharma Inc., Janssen Research & Development, LLC, Janssen Pharmaceutical K.K.
Conditions
Chronic Hepatitis CHealthyHepatitis C, Chronic
Phase 1
Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants
CompletedNCT02824315
Start: 2016-05-31End: 2016-10-31Updated: 2025-02-03
To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants
CompletedNCT02885454
Start: 2016-08-31End: 2016-12-31Updated: 2017-01-23
A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants
CompletedNCT02945020
Start: 2016-11-10End: 2017-01-20Updated: 2025-02-03
Phase 2
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
CompletedNCT02421211
Start: 2015-05-19End: 2016-01-27Updated: 2019-03-28
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir
CompletedNCT02569710
Start: 2015-10-31End: 2018-05-11Updated: 2019-07-16
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
CompletedNCT02993250
Start: 2016-12-21End: 2018-05-07Updated: 2019-09-11