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

• 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: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: November 6, 2009
• First Posted Date: November 10, 2009
• Results First Submitted Date: September 26, 2014
• Results First Posted Date: September 29, 2014
• Last Update Posted Date: October 9, 2018
• Actual Study Start Date: July 1, 2009
• Actual Primary Completion Date: June 11, 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hepatitis C

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2009): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 21, 2010
• Actual Primary Completion Date: June 11, 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT01010906
• Other Study ID Numbers: 7009-005; 2009_674
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: September 2018