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Showing 1–8 of 8 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Simeprevir (SMV) Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants

NCT02885454
View directory record Official record
Conditions
Healthy
Interventions
Drospirenone/ethinylestradiol, AL-335, Odalasvir (ODV), Simeprevir (SMV)
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jan 22, 2017 · Synced Sep 23, 2026, 2:18 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants

NCT02945020
View directory record Official record
Conditions
Healthy
Interventions
Dabigatran etexilate mesylate, Odalasvir (ODV), Simeprevir (SMV)
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
19 Years to 55 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2017
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated Feb 2, 2025 · Synced Sep 23, 2026, 2:18 PM EDT
Completed Phase 4 Interventional Results available

SMV + SOF With/Without RBV for IFN-II Patients With CHC

NCT02214420
View directory record Official record
Conditions
Hepatitis C
Interventions
Simeprevir, Sofosbuvir, Ribavirin
Drug
Lead sponsor
SC Liver Research Consortium, LLC
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
3
States / cities
La Jolla, California • New York, New York • Murray, Utah
Source: ClinicalTrials.gov public record
Updated Jun 18, 2018 · Synced Sep 23, 2026, 2:18 PM EDT
Completed Phase 2 Interventional Results available

Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

NCT02349048
View directory record Official record
Conditions
Hepatitis C Virus
Interventions
Simeprevir 150 mg, Daclatasvir 60 mg, Sofosbuvir 400 mg
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years to 70 Years
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
7
States / cities
Bakersfield, California • Jacksonville, Florida • Lutherville, Maryland + 4 more
Source: ClinicalTrials.gov public record
Updated Feb 28, 2017 · Synced Sep 23, 2026, 2:18 PM EDT
Withdrawn Phase 4 Interventional

Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1

NCT02485080
View directory record Official record
Conditions
PT-NANBH
Interventions
Simeprevir, Sofosbuvir
Drug
Lead sponsor
Stanford University
Other
Eligibility
18 Years to 72 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
2
States / cities
Palo Alto, California • New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Oct 12, 2016 · Synced Sep 23, 2026, 2:18 PM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

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-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)

NCT03059303
View directory record Official record
Conditions
Healthy
Interventions
Simeprevir 75 mg, Odalasvir 25 mg, Odalasvir 12.5 mg, Odalasvir 75 mg, AL-335 800 mg, Lansoprazole 30 mg, Omeprazole 20 mg
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years to 55 Years
Enrollment
72 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated Dec 21, 2017 · Synced Sep 23, 2026, 2:18 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants

NCT03155893
View directory record Official record
Conditions
Healthy
Interventions
ODV Placebo (Matching 25 mg ODV), ODV Placebo (Matching 200 mg ODV), ODV Placebo (Matching 125 mg ODV), ODV Placebo (Matching 100 mg ODV), SMV Placebo (Matching 150 mg SMV), AL-335 Placebo (matching 1200 mg AL-335), Moxifloxacin Placebo (matching 400 mg moxifloxacin), ODV 25 mg, ODV 200 mg, ODV 125 mg, ODV 100 mg, SMV 150 mg, AL-335 1200 mg
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years to 55 Years
Enrollment
59 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated Nov 13, 2017 · Synced Sep 23, 2026, 2:18 PM EDT
Terminated Phase 3 Interventional Results available

Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis

NCT02455167
View directory record Official record
Conditions
Hepatitis C
Interventions
Simeprivir (SMV), Sofosbuvir (SOF), Ribavirin (RBV)
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 80 Years
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Denver, Colorado
Source: ClinicalTrials.gov public record
Updated Sep 12, 2021 · Synced Sep 23, 2026, 2:18 PM EDT