Safety, Tolerability, PK and PD of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With HCV Genotype 1 (Protocol No. P04695)

PHASE1CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Hepatitis C, Chronic
Interventions
DRUG

Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron)

"Drug: 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

Drug: SCH 900518 Biologic: Peginterferon alfa-2b

"Drug: 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

Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)

"Drug: 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

Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)

"Drug: 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."

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01081158 - Safety, Tolerability, PK and PD of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With HCV Genotype 1 (Protocol No. P04695) | Biotech Hunter | Biotech Hunter