A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)
- Registration Number
- NCT01593735
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel E: GT3, high dose Placebo Participants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days. Panel B: GT1, lower dose MK-2748 Participants with GT1 HCV will receive lower dose MK-2748 daily for 7 days. Panel B: GT1, lower dose Placebo Participants with GT1 HCV will receive lower dose MK-2748 daily for 7 days. Panel G: GT1, dose based on Panels A+B+C Placebo Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C. Panel H: GT1, dose based on Panels A+B+C+G Placebo Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G. Panel I: GT3, dose based on Panels E+F Placebo Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F. Panel A: GT1, low dose Placebo Participants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days. Panel C: GT1, dose based on Panels A+B Placebo Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose). Panel G: GT1, dose based on Panels A+B+C MK-2748 Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C. Panel D: GT3, low dose (Omitted) Placebo Participants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel. Panel F: GT3, dose based on Panel E Placebo Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose). Panel J: GT3, dose based on Panels E+F+I Placebo Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I. Panel A: GT1, low dose MK-2748 Participants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days. Panel C: GT1, dose based on Panels A+B MK-2748 Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose). Panel H: GT1, dose based on Panels A+B+C+G MK-2748 Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G. Panel D: GT3, low dose (Omitted) MK-2748 Participants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel. Panel J: GT3, dose based on Panels E+F+I MK-2748 Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I. Panel I: GT3, dose based on Panels E+F MK-2748 Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F. Panel F: GT3, dose based on Panel E MK-2748 Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose). Panel E: GT3, high dose MK-2748 Participants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days.
- Primary Outcome Measures
Name Time Method Number of participants experiencing clinical or laboratory adverse events (AEs) From first dose up to 21 days Number of participants discontinued from study treatment due to AEs From Day 1 through Day 7 Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT3 HCV-infected participants Predose on Day 1 through Day 56 Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants Predose on Day 1 through Day 56
- Secondary Outcome Measures
Name Time Method Plasma concentration of MK-2748 (C24) on Day 7 of dosing 24 hours post-dose on Day 7 Area under the plasma concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-2748 Day 1 and Day 7, predose through 24 hours post-dose