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Samatasvir · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV | EXPERIMENTAL | Part A: Participants with genotype 1b or 4 received samatasvir 50 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV | EXPERIMENTAL | Part A: Participants with genotype 1b or 4 received samatasvir 100 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV | EXPERIMENTAL | Part A: Participants with genotype 1b or 4 received samatasvir 150 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV | EXPERIMENTAL | Part B: Participants with genotype 1b or 4 received samatasvir 25 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV | EXPERIMENTAL | Part B: Participants with genotype 1b or 4 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part B: GT 6 - samatasvir 100/simeprevir/RBV | EXPERIMENTAL | Part B: Participants with Genotype 6 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV | EXPERIMENTAL | Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily plus RTV 30 mg once daily for 12 weeks |
| Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV | EXPERIMENTAL | Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily, plus RTV 30 mg once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| 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. |
| 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) |
| Name | Type | Description |
|---|---|---|
| Samatasvir | DRUG | Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets. |
| Simeprevir | DRUG | Simeprevir will be supplied as 75 and 150 mg oral capsules. |
| Ribavirin (RBV) | DRUG | Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment. |
| TMC647055 | DRUG | TMC647055 will be supplied as 150 mg oral capsules. |
| Ritonavir (RTV) | DRUG | Ritonavir will be supplied as 80 mg/mL oral solution. |
| Pegylated interferon (Peg-IFN) | BIOLOGICAL | Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment. |
| Samatasvir matching placebo | OTHER | Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A. |
| Omeprazole | DRUG | 40 mg delayed-release oral capsules, once daily |
| Ritonavir | DRUG | 100 mg oral tablets, once daily |
| Samatasvir tablet | DRUG | Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose) |
| Samatasvir capsule | DRUG | Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose) |
Inclusion Criteria: * Must have Genotype 1a, 1b, 4 or 6 HCV infection. * Documented clinical history compatible with chronic hepatitis C * HCV treatment-naïve or interferon/RBV-treatment relapsed (Part C) * Must agree to use an acceptable double method of birth control (one of which must be a barri...
Samatasvir is an investigational small molecule being developed for the treatment of Hepatitis C, including chronic Hepatitis C virus and chronic Hepatitis C infection. It is being studied in combination with other antiviral agents for chronic Hepatitis C infection. The drug is currently in clinical development and is not approved by the FDA.
Samatasvir is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company has conducted clinical trials to evaluate the drug's safety, pharmacokinetics, and efficacy in treating Hepatitis C and chronic Hepatitis C infection.
Samatasvir is in Phase 1 of clinical development. Clinical trials have been completed for the drug, including a Phase 1 study evaluating its relative bioavailability and food effect in healthy participants. No active trials are currently listed, and the drug remains investigational.
Samatasvir has been studied in clinical trials including NCT01335607, a Phase 1 open-label study in healthy male participants with Hepatitis C, and NCT01813552, a Phase 1 study evaluating the effect of ritonavir or omeprazole on its pharmacokinetics. A Phase 2 trial, NCT01852604, evaluated Samatasvir in combination with simeprevir and/or TMC647055/ritonavir with or without ribavirin in participants with chronic Hepatitis C infection.
Samatasvir is also known as IDX719 in some clinical trials. The drug was previously referred to as IDX184 in an early Phase 1 study. These names refer to the same investigational compound being developed by Merck & Company, Inc. for Hepatitis C.