An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-7009
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 60
- Primary Endpoint
- Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Mild Hepatic Insufficiency (HI)
Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
Intervention: Vaniprevir 300 mg (Drug)
Healthy Control to Mild HI
Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir
Intervention: Vaniprevir 300 mg (Drug)
Moderate HI
Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
Intervention: Vaniprevir 300 mg (Drug)
Healthy Control to Moderate HI
Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir
Intervention: Vaniprevir 300 mg (Drug)
Severe HI
Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
Intervention: Vaniprevir 200 mg (Drug)
Healthy Control to Severe HI
Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir
Intervention: Vaniprevir 200 mg (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration(0-48 hours postdose)