A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
- Registration Number
- NCT00998985
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 91
- Baseline health is stable.
- Has a clinical diagnosis of chronic HCV infection.
- Has a history of stroke or chronic seizures.
- Has a history of cancer.
- Has a history of human immunodeficiency virus (HIV) infection.
- Has had major surgery, donated blood or participated in another investigational study within the past 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 30 mg Grazoprevir - GT1 Placebo GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo 50 mg Grazoprevir - GT3 Placebo GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo 600 mg Grazoprevir - GT3 Placebo GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo 800 mg Grazoprevir - GT3 Placebo GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo 200 mg Grazoprevir - GT1 Placebo GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo 100 mg Grazoprevir - GT1 Placebo GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo 400 mg Grazoprevir - GT1 Placebo GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo 200 mg Grazoprevir - GT3 Placebo GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo 100 mg Grazoprevir - GT3 Placebo GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo 800 mg Grazoprevir - GT1 Placebo GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo 400 mg Grazoprevir - GT3 Placebo GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo 600 mg Grazoprevir - GT1 Placebo GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo 50 mg Grazoprevir - GT1 Placebo GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo 10 mg Grazoprevir - GT1 Placebo GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo 400 mg Grazoprevir - GT1 Grazoprevir GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo 400 mg Grazoprevir - GT3 Grazoprevir GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo 600 mg Grazoprevir - GT1 Grazoprevir GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo 800 mg Grazoprevir - GT1 Grazoprevir GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo 600 mg Grazoprevir - GT3 Grazoprevir GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo 800 mg Grazoprevir - GT3 Grazoprevir GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo 100 mg Grazoprevir - GT1 Grazoprevir GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo 200 mg Grazoprevir - GT1 Grazoprevir GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo 50 mg Grazoprevir - GT1 Grazoprevir GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo 200 mg Grazoprevir - GT3 Grazoprevir GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo 100 mg Grazoprevir - GT3 Grazoprevir GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo 50 mg Grazoprevir - GT3 Grazoprevir GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo 30 mg Grazoprevir - GT1 Grazoprevir GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo 10 mg Grazoprevir - GT1 Grazoprevir GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo
- Primary Outcome Measures
Name Time Method Number of Participants With Clinical and Laboratory Adverse Events (AEs) All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days) An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
- Secondary Outcome Measures
Name Time Method Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo Baseline and up to approximately 2 months Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL.
24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7 Day 7 at 24 hours post-dose Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM.
Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7 Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr.
Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo Baseline and up to approximately 2 months Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA.