A Study of MK-5172 in Hepatitis C-Infected Male Participants (MK-5172-004 AM3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00998985
First received: October 20, 2009
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-5172 in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants.


Condition Intervention Phase
Hepatitis C
Drug: MK-5172
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK5172 in Hepatitis C Infected Male Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Patients with Clinical and Laboratory Adverse Experiences [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the curve (AUC[0-24hr]) of MK5172 on Day 7 of dosing [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • 24 hour plasma concentration (C[24]) of MK5172 on Day 7 of dosing [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • HCV viral load following administration of MK-5172 compared to placebo [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: February 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A
GT1 HCV-infected Patients: 400 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel B
GT1 HCV-infected Patients: 600 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel C
GT1 HCV-infected Patients: 800 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel D
GT3 HCV-infected Patients: 400 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel E
GT3 HCV-infected Patients: 600 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel F
GT3 HCV-infected Patients: 800 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel G
GT1 HCV-infected Patients: 200 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel H
GT1 HCV-infected Patients: 100 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel I
GT1 HCV-infected Patients: 50 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel J
GT3 HCV-infected Patients: 200 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel K
GT3 HCV-infected Patients: 100 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel L
GT3 HCV-infected Patients: 50 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel M
GT1 HCV-infected Patients: 30 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
Experimental: Panel N
GT1 HCV-infected Patients: 10 mg MK5172 or Placebo
Drug: MK-5172
10, 30, 50, 100, 200, 400, 600 or 800 mg MK5172 tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients baseline health is stable.
  • Patient has a clinical diagnosis of chronic HCV infection.

Exclusion Criteria:

  • Patient has a history of stroke or chronic seizures.
  • Patient has a history of cancer.
  • Patient has a history of HIV infection.
  • Patient has had major surgery, donated blood or participated in another investigational study within the past 3 months.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00998985     History of Changes
Other Study ID Numbers: 5172-004, 2009_678
Study First Received: October 20, 2009
Last Updated: October 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014