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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.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Vaniprevir 300 mg
Drug: Vaniprevir 200 mg
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mild Hepatic Insufficiency (HI) Healthy Control for Mild HI Moderate HI Healthy Control for Moderate HI Severe HI Healthy Control for Severe HI
Hide Arm/Group Description Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir Healthy matched 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 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 control participants administered a single 200 mg oral tablet of vaniprevir
Period Title: Overall Study
Started 10 10 10 10 10 10
Completed 10 10 10 10 10 10
Not Completed 0 0 0 0 0 0
Arm/Group Title Mild Hepatic Insufficiency (HI) Healthy Control for Mild HI Moderate HI Healthy Control for Moderate HI Severe HI Healthy Control for Severe HI Total
Hide Arm/Group Description Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir Healthy matched 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 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 control participants administered a single 200 mg oral tablet of vaniprevir Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 10 10 10 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants 60 participants
50.3  (5.03) 52.1  (3.54) 52.1  (6.51) 53.3  (4.90) 53.4  (6.08) 52.6  (7.04) 52.3  (5.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants 60 participants
Female
2
  20.0%
2
  20.0%
1
  10.0%
1
  10.0%
4
  40.0%
4
  40.0%
14
  23.3%
Male
8
  80.0%
8
  80.0%
9
  90.0%
9
  90.0%
6
  60.0%
6
  60.0%
46
  76.7%
1.Primary Outcome
Title Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants administered at least one dose of investigational drug. AUC for one participant with Mild HI was not estimated due to poor correlation of the linear regression.
Arm/Group Title Mild Hepatic Insufficiency (HI) Healthy Control for Mild HI Moderate HI Healthy Control for Moderate HI Severe HI Healthy Control for Severe HI
Hide Arm/Group Description:
Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
Healthy matched 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 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 control participants administered a single 200 mg oral tablet of vaniprevir
Overall Number of Participants Analyzed 9 10 10 10 10 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: µM.hr
2.68
(1.39 to 5.18)
1.48
(0.84 to 2.59)
5.09
(2.21 to 11.70)
1.64
(0.67 to 3.98)
7.79
(5.03 to 12.00)
0.925
(0.61 to 1.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild Hepatic Insufficiency (HI), Healthy Control for Mild HI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the 90% Confidence Interval falls within the interval [0.50, 2.00], then treatment of HI participants is similar to treatment of healthy matched for mild HI participants.
Method of Estimation Estimation Parameter Geometric Least-Square Mean Ratio
Estimated Value 1.82
Confidence Interval (2-Sided) 90%
0.96 to 3.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Moderate HI, Healthy Control for Moderate HI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the 90% Confidence Interval falls within the interval [0.50, 2.00], then treatment of HI participants is similar to treatment of healthy matched for moderate HI participants.
Method of Estimation Estimation Parameter Geometric Least-Square Mean Ratio
Estimated Value 3.11
Confidence Interval (2-Sided) 90%
1.60 to 6.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Severe HI, Healthy Control for Severe HI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the 90% Confidence Interval falls within the interval [0.50, 2.00], then treatment of HI participants is similar to treatment of healthy matched for severe HI participants.
Method of Estimation Estimation Parameter Geometric Least-Square Mean Ratio
Estimated Value 8.42
Confidence Interval (2-Sided) 90%
5.20 to 13.64
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants administered at least one dose of investigational drug.
Arm/Group Title Mild Hepatic Insufficiency (HI) Healthy Control for Mild HI Moderate HI Healthy Control for Moderate HI Severe HI Healthy Control for Severe HI
Hide Arm/Group Description:
Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
Healthy matched 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 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 control participants administered a single 200 mg oral tablet of vaniprevir
Overall Number of Participants Analyzed 10 10 10 10 10 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: µM
0.922
(0.44 to 1.94)
0.586
(0.29 to 1.17)
1.88
(0.88 to 4.01)
0.852
(0.38 to 1.91)
2.06
(1.37 to 3.12)
0.335
(0.23 to 0.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild Hepatic Insufficiency (HI), Healthy Control for Mild HI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least-Square Mean Ratio
Estimated Value 1.57
Confidence Interval (2-Sided) 90%
0.76 to 3.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Moderate HI, Healthy Control for Moderate HI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least-Square Mean Ratio
Estimated Value 2.21
Confidence Interval (2-Sided) 90%
1.21 to 4.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Severe HI, Healthy Control for Severe HI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least-Square Mean Ratio
Estimated Value 6.16
Confidence Interval (2-Sided) 90%
3.90 to 9.71
Estimation Comments [Not Specified]
Time Frame Up to 14 days after administration of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mild Hepatic Insufficiency (HI) Healthy Control for Mild HI Moderate HI Healthy Control for Moderate HI Severe HI Healthy Control for Severe HI
Hide Arm/Group Description Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir Healthy matched 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 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 control participants administered a single 200 mg oral tablet of vaniprevir
All-Cause Mortality
Mild Hepatic Insufficiency (HI) Healthy Control for Mild HI Moderate HI Healthy Control for Moderate HI Severe HI Healthy Control for Severe HI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Mild Hepatic Insufficiency (HI) Healthy Control for Mild HI Moderate HI Healthy Control for Moderate HI Severe HI Healthy Control for Severe HI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mild Hepatic Insufficiency (HI) Healthy Control for Mild HI Moderate HI Healthy Control for Moderate HI Severe HI Healthy Control for Severe HI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      1/10 (10.00%)      1/10 (10.00%)      2/10 (20.00%)      0/10 (0.00%)      0/10 (0.00%)    
Blood and lymphatic system disorders             
Hypersplenism † 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Thrombocytopenia † 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Hepatobiliary disorders             
Hepatic cirrhosis † 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Investigations             
Blood bilirubin increased † 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  3 0/10 (0.00%)  0 0/10 (0.00%)  0
Nervous system disorders             
Dysgeusia † 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Headache † 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01010906    
Other Study ID Numbers: 7009-005
2009_674
First Submitted: November 6, 2009
First Posted: November 10, 2009
Results First Submitted: September 26, 2014
Results First Posted: September 29, 2014
Last Update Posted: October 9, 2018