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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-08C-002 |
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The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDX184 5 mg | Experimental | Healthy participants will be administered a single 5 mg dose of IDX184. |
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| IDX184 10 mg | Experimental | Healthy participants will be administered a single 10 mg dose of IDX184. |
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| IDX184 25 mg | Experimental | Healthy participants will be administered a single 25 mg dose of IDX184. |
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| IDX184 50 mg | Experimental | Healthy participants will be administered a single 50 mg dose of IDX184. |
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| IDX184 75 mg | Experimental | Healthy participants will be administered a single 75 mg dose of IDX184. |
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| IDX184 100 mg | Experimental | Healthy participants will be administered a single 100 mg dose of IDX184. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDX184 | Drug | IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants experiencing serious adverse events (SAEs) | Up to Day 6 | |
| Percentage of participants experiencing AEs | Up to Day 6 | |
| Percentage of participants experiencing dose-limiting toxicity (DLTs) | Up to Day 6 | |
| Percentage of participants experiencing grade 1-4 laboratory abnormalities | Up to Day 6 |
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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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21060109 | Result | Zhou XJ, Pietropaolo K, Chen J, Khan S, Sullivan-Bolyai J, Mayers D. Safety and pharmacokinetics of IDX184, a liver-targeted nucleotide polymerase inhibitor of hepatitis C virus, in healthy subjects. Antimicrob Agents Chemother. 2011 Jan;55(1):76-81. doi: 10.1128/AAC.01101-10. Epub 2010 Nov 8. |
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| 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 |
|---|---|
| C557801 | IDX184 |
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| Placebo | Placebo Comparator | Healthy participants will be administered placebo matching IDX184. |
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| Placebo | Drug | Placebo supplied as size 3, white opaque capsules matching IDX184 capsules. |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |