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

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ClinicalTrials.gov Identifier: NCT01010906
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : September 29, 2014
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 6, 2009
First Posted Date  ICMJE November 10, 2009
Results First Submitted Date  ICMJE September 26, 2014
Results First Posted Date  ICMJE September 29, 2014
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE July 1, 2009
Actual Primary Completion Date June 11, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2014)
Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration [ Time Frame: 0-48 hours postdose ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2009)
AUC(0-infinity) of MK7009 following single dose administration [ Time Frame: 48 hours postdose ]
Change History Complete list of historical versions of study NCT01010906 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2014)
Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration [ Time Frame: 0-48 hours postdose ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)
Official Title  ICMJE An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-7009
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Vaniprevir 300 mg
    single dose administration of 300 mg oral tablet
    Other Name: MK-7009
  • Drug: Vaniprevir 200 mg
    single dose administration of 200 mg oral tablet
    Other Name: MK-7009
Study Arms  ICMJE
  • Experimental: Mild Hepatic Insufficiency (HI)
    Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
    Intervention: Drug: Vaniprevir 300 mg
  • Experimental: Healthy Control to Mild HI
    Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir
    Intervention: Drug: Vaniprevir 300 mg
  • Experimental: Moderate HI
    Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
    Intervention: Drug: Vaniprevir 300 mg
  • Experimental: Healthy Control to Moderate HI
    Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir
    Intervention: Drug: Vaniprevir 300 mg
  • Experimental: Severe HI
    Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
    Intervention: Drug: Vaniprevir 200 mg
  • Experimental: Healthy Control to Severe HI
    Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir
    Intervention: Drug: Vaniprevir 200 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 21, 2010
Actual Primary Completion Date June 11, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT01010906
Other Study ID Numbers  ICMJE 7009-005
2009_674
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP