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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Vaniprevir 300 mg
Vaniprevir 200 mg
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Mild Hepatic Insufficiency (HI)

    Healthy Control to Mild HI

    Moderate HI

    Healthy Control to Moderate HI

    Severe HI

    Healthy Control to Severe HI

    Arm Description

    Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir

    Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir

    Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir

    Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir

    Participants with severe HI administered a single 200 mg oral tablet of vaniprevir

    Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir

    Outcomes

    Primary Outcome Measures

    Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration
    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
    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.

    Full Information

    First Posted
    November 6, 2009
    Last Updated
    September 10, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01010906
    Brief Title
    A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)
    Official Title
    An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-7009
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2009 (Actual)
    Primary Completion Date
    June 11, 2010 (Actual)
    Study Completion Date
    June 21, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mild Hepatic Insufficiency (HI)
    Arm Type
    Experimental
    Arm Description
    Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
    Arm Title
    Healthy Control to Mild HI
    Arm Type
    Experimental
    Arm Description
    Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir
    Arm Title
    Moderate HI
    Arm Type
    Experimental
    Arm Description
    Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
    Arm Title
    Healthy Control to Moderate HI
    Arm Type
    Experimental
    Arm Description
    Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir
    Arm Title
    Severe HI
    Arm Type
    Experimental
    Arm Description
    Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
    Arm Title
    Healthy Control to Severe HI
    Arm Type
    Experimental
    Arm Description
    Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir
    Intervention Type
    Drug
    Intervention Name(s)
    Vaniprevir 300 mg
    Other Intervention Name(s)
    MK-7009
    Intervention Description
    single dose administration of 300 mg oral tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Vaniprevir 200 mg
    Other Intervention Name(s)
    MK-7009
    Intervention Description
    single dose administration of 200 mg oral tablet
    Primary Outcome Measure Information:
    Title
    Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration
    Description
    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.
    Time Frame
    0-48 hours postdose
    Secondary Outcome Measure Information:
    Title
    Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration
    Description
    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.
    Time Frame
    0-48 hours postdose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=7009-005&kw=7009-005&tab=access

    Learn more about this trial

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

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