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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-08C-006 | Other Identifier | Idenix Protocol Number |
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The purpose of this study is to:
Each participant will receive each of the formulations in a crossover design. Part A Periods 1 and 2: Participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants will receive samatasvir tablets under fed conditons on Day 15.
Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive samatasvir capsules under fed conditons on Day 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Samatasvir cap→tab→tab; Part B: cap | Active Comparator | Part A: Samatasvir capsule as a single dose on Day 1 (fasting state) followed by samatasvir tablet as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) |
|
| Part A: Samatasvir tab→cap→tab; Part B: cap | Active Comparator | Part A: Samatasvir tablet as a single dose on Day 1 (fasting state) followed by samatasvir capsule as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samatasvir tablet | Drug | Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter: Observed maximum plasma drug concentration (Cmax) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | |
| Pharmacokinetic parameter: Time to maximum concentration (Tmax) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | |
| Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to last measurable concentration (AUC 0-t) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | |
| Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to 24 hours (AUC 0-24) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours | |
| Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to infinity (AUC 0-infinity) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | |
| Pharmacokinetic parameter: Plasma concentration at 24 hours post dose (C24h) | 24 hours | |
| Pharmacokinetic parameter: Observed plasma terminal half-life (T1/2) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | |
| Pharmacokinetic parameter: Apparent oral total plasma clearance (CL/F) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who experienced an adverse event | Up to Day 20 | |
| Percentage of participants who experienced a serious adverse event | Up to Day 20 | |
| Percentage of participants who experienced a Grade 1-4 laboratory abnormality |
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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 |
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| Samatasvir capsule | Drug | Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose) |
|
| Pharmacokinetic parameter: Apparent oral total plasma volume of distribution (Vz/F) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours |
| Up to Day 20 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |