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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_674 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Hepatic Insufficiency (HI) | Experimental | Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir |
|
| Healthy Control to Mild HI | Experimental | Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir |
|
| Moderate HI | Experimental | Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir |
|
| Healthy Control to Moderate HI | Experimental | Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir |
|
| Severe HI | Experimental | Participants with severe HI administered a single 200 mg oral tablet of vaniprevir |
|
| Healthy Control to Severe HI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaniprevir 300 mg | Drug | single dose administration of 300 mg oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) 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 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. |
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Inclusion Criteria:
Hepatic Participants:
Healthy Matched Participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mild Hepatic Insufficiency (HI) | Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir |
| FG001 | Healthy Control for Mild HI | Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir |
| FG002 | Moderate HI | Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir |
| FG003 | Healthy Control for Moderate HI | Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir |
| FG004 | Severe HI | Participants with severe HI administered a single 200 mg oral tablet of vaniprevir |
| FG005 | Healthy Control for Severe HI | Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Hepatic Insufficiency (HI) | Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir |
| BG001 | Healthy Control for Mild HI | Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µM.hr | 0-48 hours postdose |
|
Up to 14 days after administration of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild Hepatic Insufficiency (HI) | Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersplenism | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C540393 | vaniprevir |
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Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir |
|
|
| Vaniprevir 200 mg | Drug | single dose administration of 200 mg oral tablet |
|
|
| 0-48 hours postdose |
| BG002 | Moderate HI | Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir |
| BG003 | Healthy Control for Moderate HI | Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir |
| BG004 | Severe HI | Participants with severe HI administered a single 200 mg oral tablet of vaniprevir |
| BG005 | Healthy Control for Severe HI | Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Healthy Control for Mild HI | Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir |
| OG002 | Moderate HI | Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir |
| OG003 | Healthy Control for Moderate HI | Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir |
| OG004 | Severe HI | Participants with severe HI administered a single 200 mg oral tablet of vaniprevir |
| OG005 | Healthy Control for Severe HI | Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir |
|
|
|
| Secondary | Maximum Concentration (Cmax) 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 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. | Participants administered at least one dose of investigational drug. | Posted | Geometric Mean | 95% Confidence Interval | µM | 0-48 hours postdose |
|
|
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Healthy Control for Mild HI | Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir | 0 | 10 | 1 | 10 |
| EG002 | Moderate HI | Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir | 0 | 10 | 1 | 10 |
| EG003 | Healthy Control for Moderate HI | Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir | 0 | 10 | 2 | 10 |
| EG004 | Severe HI | Participants with severe HI administered a single 200 mg oral tablet of vaniprevir | 0 | 10 | 0 | 10 |
| EG005 | Healthy Control for Severe HI | Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir | 0 | 10 | 0 | 10 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
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.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Geometric Least-Square Mean Ratio |
| 2.21 |
| 2-Sided |
| 90 |
| 1.21 |
| 4.03 |
| Superiority or Other |
| Geometric Least-Square Mean Ratio | 6.16 | 2-Sided | 90 | 3.90 | 9.71 | Superiority or Other |