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

NCT01010906 | Completed Phase 1 Results

• 2 other identifiers: 7009-0052009_674
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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.

  0-48 hours postdose

Secondary Outcomes (1)

• Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration

  0-48 hours postdose

Study Arms (6)

Mild Hepatic Insufficiency (HI)

EXPERIMENTAL

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

Drug: Vaniprevir 300 mg

Healthy Control to Mild HI

EXPERIMENTAL

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

Drug: Vaniprevir 300 mg

Moderate HI

EXPERIMENTAL

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

Drug: Vaniprevir 300 mg

Healthy Control to Moderate HI

EXPERIMENTAL

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

Drug: Vaniprevir 300 mg

Severe HI

EXPERIMENTAL

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

Drug: Vaniprevir 200 mg

Healthy Control to Severe HI

EXPERIMENTAL

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

Drug: Vaniprevir 200 mg

Interventions

Vaniprevir 300 mg DRUG

single dose administration of 300 mg oral tablet

Also known as: MK-7009

Healthy Control to Mild HI; Healthy Control to Moderate HI; Mild Hepatic Insufficiency (HI); Moderate HI

Vaniprevir 200 mg DRUG

single dose administration of 200 mg oral tablet

Also known as: MK-7009

Healthy Control to Severe HI; Severe HI

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

vaniprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 10, 2009
• Study Start: July 1, 2009
• Primary Completion: June 11, 2010
• Study Completion: June 21, 2010
• Last Updated: October 9, 2018
• Results First Posted: September 29, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share