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SCH 900518 Biologic: Peginterferon alfa-2b

Phase 1

Hepatitis C, Chronic | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Feb 9, 2015

Target and mechanism

ModalitySmall molecule

Also known as Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron), Drug: SCH 900518 Biologic: Peginterferon alfa-2b

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

SCH 900518 Biologic: Peginterferon alfa-2b · 1 trial · 1 indication

Phase 1 1
NCT01081158Safety, Tolerability, PK and PD of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With HCV Genotype 1 (Protocol No. P04695)Hepatitis C, Chronic
COMPLETED41 Analytics
PHASE1COMPLETED
Safety, Tolerability, PK and PD of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With HCV Genotype 1 (Protocol No. P04695)
Hepatitis C, Chronic
NCT0108115841
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Study Endpoints

Primary Endpoints

Safety and tolerability were to be assessed by collecting adverse events (AEs), vital signs, electrocardiograms (ECGs), physical examinations, urinalysis, and safety laboratory tests.
Screening Period: 90 days, Period 1: 7 days, Washout: 4 weeks, Period 2: 14 days, Standard of Care with PegIntron and ribavirin: 84 days

Secondary Endpoints

Log change in HCV-RNA from baseline. Ctrough of SCH 900518 resulting in mean HCV RNA decrease > 2 log10 IU/mL. Ctrough of SCH 900518+PEG resulting in HCV-RNA < LOQ. SCH 900518 PK: Cmax, Tmax, AUC, Ctrough, t½, R, CL/F, Vd/F. PEG and RTV: Ctrough
Period 1: 7 days, Washout: 4 weeks, Period 2: 14 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment-naïve 800 mg TIDEXPERIMENTALPeriod 1: SCH 900518 (800 mg TID) or placebo for 7 days Period 2: SCH 900518 (800 mg TID) + PegIntron (1.5 µg/kg QW) or placebo + PegIntron for 14 days.
Treatment-experienced: 800 mg TIDEXPERIMENTALPeriod 1: SCH 900518 (800 mg TID) or placebo for 7 days Period 2: SCH 900518 (800 mg TID) + PegIntron (1.5 ug/kg QW) or placebo + PegIntron for 14 days
Treatment-naïve: 400 mg + RTV BIDEXPERIMENTALPeriod 1: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) for 7 days. Period 2: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) +PegIntron (1.5 µg/kg QW) for 14 days.
Treatment-experienced: 400 mg + RTV BIDEXPERIMENTALPeriod 1: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) for 7 days. Period 2: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) +PegIntron (1.5 µg/kg QW) for 14 days.

Interventions

NameTypeDescription
Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron)DRUGDrug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron) Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days . Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly.
Drug: SCH 900518 Biologic: Peginterferon alfa-2bDRUGDrug: SCH 900518 Biologic: Peginterferon alfa-2b Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly.
Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)DRUGDrug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron) Period 1: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension + ritonavir (200 mg BID) (2-100 mg oral capsules) for 7 days. Period 2: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension+ ritonavir (200 mg BID) (2-100 mg oral capsules) + PegIntron (1.5 µg/kg QW) for 14 days.
Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)DRUGDrug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron) Period 1, Amorphous SCH 900518 (400 mg) or placebo BID administered as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) for 7 days. Period 2, SCH 900518 (400 mg) or placebo BID as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) +PegIntron (1.5 µg/kg SC QW) for 14 days.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject infected with HCV genotype 1 (any sub-type) virus who is: * treatment naïve (eg. to interferon and ribavirin); or * treatment experienced (non-responder and relapser): subject who received interferon based therapy and continued to have detectable HCV RNA levels at...

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