A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Grazoprevir (MK-5172) in Hepatitis C Infected Male Patients
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Hepatitis C
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 91
- Primary Endpoint
- Number of Participants With Clinical and Laboratory Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Baseline health is stable.
- •Has a clinical diagnosis of chronic HCV infection.
Exclusion Criteria
- •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.
Arms & Interventions
100 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo
Intervention: Placebo
400 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo
Intervention: Grazoprevir
400 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo
Intervention: Placebo
600 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo
Intervention: Grazoprevir
600 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo
Intervention: Placebo
800 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo
Intervention: Grazoprevir
800 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo
Intervention: Placebo
400 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo
Intervention: Grazoprevir
400 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo
Intervention: Placebo
600 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo
Intervention: Grazoprevir
600 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo
Intervention: Placebo
800 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo
Intervention: Grazoprevir
800 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo
Intervention: Placebo
200 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo
Intervention: Grazoprevir
200 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo
Intervention: Placebo
100 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo
Intervention: Grazoprevir
50 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo
Intervention: Grazoprevir
50 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo
Intervention: Placebo
200 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo
Intervention: Grazoprevir
200 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo
Intervention: Placebo
100 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo
Intervention: Grazoprevir
100 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo
Intervention: Placebo
50 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo
Intervention: Grazoprevir
50 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo
Intervention: Placebo
30 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo
Intervention: Grazoprevir
30 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo
Intervention: Placebo
10 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo
Intervention: Grazoprevir
10 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With Clinical and Laboratory Adverse Events (AEs)
Time Frame: 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 Outcomes
- 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)
- 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7(Day 7 at 24 hours post-dose)
- 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)
- 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)