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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-06A -008 |
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The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Child-Pugh Class A | Experimental | Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
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| Cohort 2: Child-Pugh Class B | Experimental | Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
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| Cohort 3: Child-Pugh Class C | Experimental | Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDX719 | Drug | IDX719 supplied as 50 mg tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Up to 6 days | |
| Time to maximum plasma concentration (Tmax) | Up to 6 days | |
| Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last) | Up to 6 days | |
| AUC from time zero to infinity (AUC0-~) | Up to 6 days | |
| AUC from time zero to 24 hours (AUC0-24h) | Up to 6 days | |
| Plasma concentration 24 hours after dosing (C24h) | Up to 6 days | |
| Apparent terminal elimination rate constant | Up to 6 days | |
| Observed terminal half-life (T1/2) | Up to 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants experiencing serious adverse events (SAEs) | Up to 6 days | |
| Percentage of participants experiencing an adverse event (AE) | Up to 6 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000597389 | samatasvir |
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|
| Percentage of participants experiencing Grade 1-4 laboratory abnormalities |
| Up to 6 days |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |