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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-06A-001 | Other Identifier | Idenix Pharmaceuticals, Inc |
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The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Healthy Participants | Experimental | Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses. |
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| Group B: HCV Participants | Experimental | Treatment-naive participants infected with HCV genotype (GT) 1, GT2, or GT3 take IDX719 (1 mg - 100 mg) or matching placebo as either 1 single dose or as 7 daily doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDX719 | Drug | IDX719 liquid suspension (1 - 100 mg) taken by mouth. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants experiencing an adverse event (AE) | Up to 14 days | |
| Percentage of participants experiencing serious AEs (SAEs) | Up to 14 days | |
| Change in HCV ribonucleic acid (RNA) | Baseline and Day 10 | |
| Maximum plasma drug concentration (Cmax) | Pre-dose Day 1 to Day 13 | |
| Time to maximum plasma drug concentration (Tmax) | Pre-dose Day 1 to Day 13 | |
| Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t) | Pre-dose Day 1 to Day 13 | |
| AUC from time zero to time 24 hours (AUC0-24h) | Pre-dose Day 1 to Day 1 | |
| AUC from time zero to time infinity (AUC0-~) | Pre-dose Day 1 to Day 13 | |
| Pre-dose trough plasma drug concentration (Ctrough) | Pre-dose Day 1 | |
| Observed terminal plasma drug concentration half-life (t1/2) | Pre-dose Day 1 to Day 13 | |
| Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses) |
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Inclusion Criteria:
Exclusion Criteria:
HCV Participants
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24434503 | Result | Vince B, Hill JM, Lawitz EJ, O'Riordan W, Webster LR, Gruener DM, Mofsen RS, Murillo A, Donovan E, Chen J, McCarville JF, Sullivan-Bolyai JZ, Mayers D, Zhou XJ. A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus genotype 1, 2, 3 or 4. J Hepatol. 2014 May;60(5):920-7. doi: 10.1016/j.jhep.2014.01.003. Epub 2014 Jan 14. |
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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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| Placebo | Drug | Placebo liquid suspension matching IDX719 taken by mouth. |
|
| Pre-dose Day 1 to Day 13 |
| Apparent oral total volume of distribution (Vz/F) | Pre-dose Day 1 to Day 13 |
| Amount excreted in urine in each collection interval (Au) | Pre-dose Day 1 to Day 14 |
| Cumulative urine excretion (Au0-t) | Pre-dose Day 1 to Day 14 |
| Percentage of dose excreted in urine (% Dose excr) | Pre-dose Day 1 to Day 14 |
| Renal clearance (CLr) | Pre-dose Day 1 to Day 14 |
| Percentage of participants experiencing dose-limiting toxicity | Up to 8 days |
| Percentage of participants experiencing graded laboratory abnormalities | Up to 14 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 |