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Last Updated: September 24, 2020

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CLINICAL TRIALS PROFILE FOR SAMATASVIR

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Clinical Trials for Samatasvir

Trial ID Title Status Sponsor Phase Summary
NCT01335607 A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006) Completed Merck Sharp & Dohme Corp. Phase 1 The purpose of this study is to: - Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation) - Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting. - Determine the amount of study drug that is in the blood after eating a meal. - Evaluate the safety of the tablet form of samatasvir in healthy people.
NCT01813513 Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004) Completed Merck Sharp & Dohme Corp. Phase 1 The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.
NCT01813552 To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006) Completed Merck Sharp & Dohme Corp. Phase 1 This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.
NCT01852604 Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005) Completed Janssen Research & Development, LLC Phase 2 Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus (HCV)-infected participants. Part C of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when administered in combination with or without RBV for 12 weeks in treatment-naïve or interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.
NCT01852604 Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005) Completed Merck Sharp & Dohme Corp. Phase 2 Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus (HCV)-infected participants. Part C of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when administered in combination with or without RBV for 12 weeks in treatment-naïve or interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.
NCT01919125 Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008) Completed Merck Sharp & Dohme Corp. Phase 1 The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Samatasvir

Condition Name

Condition Name for
Intervention Trials
Chronic Hepatitis C Infection 2
Hepatitis C, Chronic 1
Hepatitis C 1
Chronic Hepatitis C Virus 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Hepatitis C 5
Hepatitis 5
Hepatitis C, Chronic 4
Hepatitis, Chronic 3
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Clinical Trial Progress for Samatasvir

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 1
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 5
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Clinical Trial Sponsors for Samatasvir

Sponsor Name

Sponsor Name for
Sponsor Trials
Merck Sharp & Dohme Corp. 5
Janssen Research & Development, LLC 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 6
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