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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR ODALASVIR

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Clinical Trials for Odalasvir

Trial ID Title Status Sponsor Phase Summary
NCT02765490 Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection Recruiting Janssen Research & Development, LLC Phase 2 The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
NCT02821858 Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants Completed Janssen Research & Development, LLC Phase 1 The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses of AL-335 in healthy Japanese participants (Panel 2; Sequential Design).
NCT02824315 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 Completed Janssen Research & Development, LLC Phase 1 The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS 022227), when these drugs are co-administered in healthy Japanese participants.
NCT02885454 To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants Recruiting Janssen Research & Development, LLC Phase 1 The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and ethinylestradiol in healthy female participants.
NCT02889367 A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants Recruiting Janssen Research & Development, LLC Phase 1 The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Odalasvir

Condition Name

Condition Name for
Intervention Trials
Healthy 7
Hepatitis C, Chronic 2
Renal Insufficiency 1
Hepatitis C 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Hepatitis C 3
Hepatitis A 3
Hepatitis 3
Hepatitis, Chronic 2
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Clinical Trial Locations for Odalasvir

Trials by Country

Trials by Country for
Location Trials
United States 8
Canada 6
Poland 2
Germany 2
Spain 2
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Trials by US State

Trials by US State for
Location Trials
Arizona 4
Texas 1
Tennessee 1
Florida 1
Kansas 1
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Clinical Trial Progress for Odalasvir

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 2
Phase 1 9
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 7
Not yet recruiting 3
Completed 2
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Clinical Trial Sponsors for Odalasvir

Sponsor Name

Sponsor Name for
Sponsor Trials
Janssen Research & Development, LLC 11
Janssen Pharmaceutical K.K. 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 12
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