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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-06A-006 | Other Identifier | Idenix Protocol Number |
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This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Samatasvir + Ritonavir | Experimental | Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fed or fasted conditions with water. Days 5-16: Healthy Volunteers will take ritonavir in the mornings under fasted or fed conditions with water. |
|
| Samatasvir + Omeprazole | Experimental | Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fasted conditions with water or Coke. Days 5-16: Healthy Volunteers will take omeprazole in the mornings under fasted conditions with water or Coke. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samatasvir | Drug | Samatasvir 150 mg oral tablets (50mg x 3), single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter: Area under the concentration-time curve (AUC) from time zero to last measurable concentration | 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours | |
| Pharmacokinetic parameter: AUC from time zero to infinity | 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours | |
| Pharmacokinetic parameter: Maximum observed drug concentration (Cmax) | 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who experienced at least one serious adverse event | Up to 17 days | |
| Percentage of participants who experienced at least one adverse event | Up to 17 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 |
|---|---|
| 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 |
| D009853 | Omeprazole |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Omeprazole | Drug | 40 mg delayed-release oral capsules, once daily |
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| Ritonavir | Drug | 100 mg oral tablets, once daily |
|
| Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality |
| Up to 17 days |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D001393 | Azoles |