Phase 1
Completed N=91
A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
Source: ClinicalTrials.gov NCT00998985 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With Clinical and Laboratory Adverse Events (AEs) — 6; 3; 13; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical and Laboratory Adverse Events (AEs) |
6; 3; 13; 4; 1; 0 | — |
| SECONDARY Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7 |
18.2; 41.9; 72.5; 3.21; 1.16; 0.419 | — |
| SECONDARY 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7 |
70.2; 93.2; 174; 22.2; 20.1; 12.7 | — |
| SECONDARY 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 |
5.14; 5.32; 5.72; 5.53; 4.74; 5.26 | — |
| SECONDARY 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 |
4.23; 5.36; 4.60; 3.32; 2.64; 0.39 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00998985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.