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

NCT00518622 | Completed Phase 1 Results

• 2 other identifiers: 7009-0042007_517
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability of MK7009

  Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication

  14 days after completion of study therapy

• Antiviral Activity of MK7009

  Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8

  Baseline and Day 8

Study Arms (8)

1

EXPERIMENTAL

25 mg b.i.d. MK7009

Drug: Comparator: MK7009

2

EXPERIMENTAL

75 mg b.i.d. MK7009

Drug: Comparator: MK7009

3

EXPERIMENTAL

250 mg b.i.d. MK7009

Drug: Comparator: MK7009

4

EXPERIMENTAL

500 mg b.i.d. MK7009

Drug: Comparator: MK7009

5

EXPERIMENTAL

700 mg b.i.d. MK7009

Drug: Comparator: MK7009

6

EXPERIMENTAL

125 mg q.d. MK7009

Drug: Comparator: MK7009

7

EXPERIMENTAL

600 mg q.d. MK7009

Drug: Comparator: MK7009

8

EXPERIMENTAL

Placebo

Drug: Comparator: Placebo

Interventions

Comparator: MK7009 DRUG

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.

Also known as: MK7009

1; 2; 3; 4; 5; 6; 7

Comparator: Placebo DRUG

MK7009 Placebo

8

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patient has evidence of advanced liver disease.
• Patient has human immunodeficiency virus (HIV)
• Patient has Hepatitis B

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.

  PMID: 23747481 RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

vaniprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2007
• First Posted: August 21, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 25, 2015
• Results First Posted: September 16, 2009

Record last verified: 2015-08