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

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by Merck:

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
ClinicalTrials.gov Identifier:	NCT00998985 History of Changes
Other Study ID Numbers:	5172-004, 2009_678
Study First Received:	October 20, 2009
Last Updated:	November 20, 2012
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 May 23, 2013