Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00518622
First received: August 17, 2007
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C


Condition Intervention Phase
Hepatitis C
Drug: Comparator: MK7009
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and Tolerability of MK7009 [ Time Frame: 14 days after completion of study therapy ] [ Designated as safety issue: Yes ]
    Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication

  • Antiviral Activity of MK7009 [ Time Frame: Baseline and Day 8 ] [ Designated as safety issue: No ]
    Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8


Enrollment: 40
Study Start Date: July 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
25 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Name: MK7009
Experimental: 2
75 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Name: MK7009
Experimental: 3
250 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Name: MK7009
Experimental: 4
500 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Name: MK7009
Experimental: 5
700 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Name: MK7009
Experimental: 6
125 mg q.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Name: MK7009
Experimental: 7
600 mg q.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Name: MK7009
Experimental: 8
Placebo
Drug: Comparator: Placebo
MK7009 Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is a man or a woman aged 18 to 55 years of age.
  • Subject has chronic Hepatitis C
  • Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Exclusion Criteria:

  • Patient has evidence of advanced liver disease.
  • Patient has human immunodeficiency virus (HIV)
  • Patient has Hepatitis B
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518622

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00518622     History of Changes
Other Study ID Numbers: 2007_517, MK7009-004
Study First Received: August 17, 2007
Results First Received: August 10, 2009
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration

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 21, 2014