Adults 18 to 65, male only, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Clinical and Laboratory Adverse Events (AEs)Primary· 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.
Group
Value
95% CI
400 mg Grazoprevir - GT1 and GT3
6
600 mg Grazoprevir - GT1 and GT3
3
800 mg Grazoprevir - GT1 and GT3
13
200 mg Grazoprevir - GT1 and GT3
4
100 mg Grazoprevir - GT1 and GT3
1
50 mg Grazoprevir - GT1
0
30 mg Grazoprevir - GT1
3
10 mg Grazoprevir - GT1
4
Placebo for Grazoprevir - GT1 and GT3
2
Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7Secondary· 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.
Group
Value
95% CI
400 mg Grazoprevir - GT1 and GT3
18.2
12.2 – 27.2
600 mg Grazoprevir - GT1 and GT3
41.9
28.0 – 62.6
800 mg Grazoprevir - GT1 and GT3
72.5
54.1 – 97.2
200 mg Grazoprevir - GT1 and GT3
3.21
2.14 – 4.80
100 mg Grazoprevir - GT1 and GT3
1.16
0.774 – 1.73
50 mg Grazoprevir - GT1
0.419
0.237 – 0.740
30 mg Grazoprevir - GT1
0.260
0.147 – 0.459
10 mg Grazoprevir - GT1
0.0628
0.0355 – 0.111
24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7Secondary· 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.
Group
Value
95% CI
400 mg Grazoprevir - GT1 and GT3
70.2
46.9 – 105
600 mg Grazoprevir - GT1 and GT3
93.2
62.3 – 140
800 mg Grazoprevir - GT1 and GT3
174
130 – 233
200 mg Grazoprevir - GT1 and GT3
22.2
14.8 – 33.2
100 mg Grazoprevir - GT1 and GT3
20.1
13.4 – 30.1
50 mg Grazoprevir - GT1
12.7
7.16 – 22.4
30 mg Grazoprevir - GT1
7.20
4.07 – 12.7
10 mg Grazoprevir - GT1
2.41
1.36 – 4.27
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 PlaceboSecondary· 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.
Group
Value
95% CI
400 mg Grazoprevir - GT1
5.14
4.55 – 5.73
600 mg Grazoprevir - GT1
5.32
4.73 – 5.91
800 mg Grazoprevir - GT1
5.72
5.38 – 6.07
200 mg Grazoprevir - GT1
5.53
4.94 – 6.12
100 mg Grazoprevir - GT1
4.74
4.15 – 5.33
50 mg Grazoprevir - GT1
5.26
4.67 – 5.85
30 mg Grazoprevir - GT1
5.06
4.47 – 5.66
10 mg Grazoprevir - GT1
3.84
3.25 – 4.43
Placebo for Grazoprevir - GT1 and GT3
0.39
0.04 – 0.73
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 PlaceboSecondary· 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.
Group
Value
95% CI
400 mg Grazoprevir - GT3
4.23
3.65 – 4.81
600 mg Grazoprevir - GT3
5.36
4.79 – 5.94
800 mg Grazoprevir - GT3
4.60
3.95 – 5.24
200 mg Grazoprevir - GT3
3.32
2.75 – 3.90
100 mg Grazoprevir - GT3
2.64
2.06 – 3.22
Placebo for Grazoprevir - GT1 and GT3
0.39
0.05 – 0.72
Adverse events — posted to ClinicalTrials.gov
Time frame: All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02601573 — Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic
· Phase 2
· completed
NCT02332720 — Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) fo
· Phase 2
· completed
NCT02332707 — Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) fo
· Phase 2
· completed
NCT02203149 — Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)
· Phase 2, PHASE3
· completed
NCT02115321 — Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Chil
· Phase 2, PHASE3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 17 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00998985.