A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Grazoprevir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00998985

5172-004

2009-015563-13 (EudraCT Number)

2009_678 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

91 participants in 14 patient groups

400 mg Grazoprevir - GT1

Experimental group

Description:

GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

600 mg Grazoprevir - GT1

Experimental group

Description:

GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

800 mg Grazoprevir - GT1

Experimental group

Description:

GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

400 mg Grazoprevir - GT3

Experimental group

Description:

GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

600 mg Grazoprevir - GT3

Experimental group

Description:

GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

800 mg Grazoprevir - GT3

Experimental group

Description:

GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

200 mg Grazoprevir - GT1

Experimental group

Description:

GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

100 mg Grazoprevir - GT1

Experimental group

Description:

GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

50 mg Grazoprevir - GT1

Experimental group

Description:

GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

200 mg Grazoprevir - GT3

Experimental group

Description:

GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

100 mg Grazoprevir - GT3

Experimental group

Description:

GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

50 mg Grazoprevir - GT3

Experimental group

Description:

GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

30 mg Grazoprevir - GT1

Experimental group

Description:

GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo

10 mg Grazoprevir - GT1

Experimental group

Description:

GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo

Treatment:

Drug: Grazoprevir

Drug: Placebo