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A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01010906
First received: November 6, 2009
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.


Condition Intervention Phase
Hepatitis C
Drug: Vaniprevir 300 mg
Drug: Vaniprevir 200 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-7009

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration [ Time Frame: 0-48 hours postdose ] [ Designated as safety issue: No ]
    Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.


Secondary Outcome Measures:
  • Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration [ Time Frame: 0-48 hours postdose ] [ Designated as safety issue: No ]
    Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.


Enrollment: 60
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mild Hepatic Insufficiency (HI)
Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
Drug: Vaniprevir 300 mg
single dose administration of 300 mg oral tablet
Other Name: MK-7009
Experimental: Healthy Control to Mild HI
Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir
Drug: Vaniprevir 300 mg
single dose administration of 300 mg oral tablet
Other Name: MK-7009
Experimental: Moderate HI
Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
Drug: Vaniprevir 300 mg
single dose administration of 300 mg oral tablet
Other Name: MK-7009
Experimental: Healthy Control to Moderate HI
Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir
Drug: Vaniprevir 300 mg
single dose administration of 300 mg oral tablet
Other Name: MK-7009
Experimental: Severe HI
Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
Drug: Vaniprevir 200 mg
single dose administration of 200 mg oral tablet
Other Name: MK-7009
Experimental: Healthy Control to Severe HI
Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir
Drug: Vaniprevir 200 mg
single dose administration of 200 mg oral tablet
Other Name: MK-7009

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Hepatic Participants:

  • Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
  • Apart from hepatic insufficiency, is in good general health
  • Has a diagnosis of chronic stable hepatic insufficiency
  • Score on the Child-Pugh scale ranged from 5 to 6 (mild hepatic insufficiency); from 7 to 9 (moderate hepatic insufficiency); from 10 to 15 (severe hepatic insufficiency). Moderate and Severe participants must have had a 50% score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, prothrombin time, bilirubin) at the prestudy visit.

Healthy Matched Participants:

  • Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
  • Is in good health

Exclusion Criteria:

  • Female is pregnant, lactating, expecting to become pregnant or donate eggs
  • Has a history of stroke or seizures
  • Has a history of cancer
  • Is unable to refrain from the use of any prescription or non-prescription medication
  • Consumes excessive amounts of alcohol or caffeinated beverages daily
  • Has had surgery, donated blood or participated in another investigational study with in the last 4 weeks
  • Is a regular user or past abuser of any illicit drug including alcohol
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010906

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01010906     History of Changes
Other Study ID Numbers: 7009-005, 2009_674
Study First Received: November 6, 2009
Results First Received: September 26, 2014
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatic Insufficiency
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014