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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014