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Also known as Samatasvir tablet, IDX719
Samatasvir · 7 trials · 4 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 |
| Cohort 1: Child-Pugh Class A | EXPERIMENTAL | Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
| Cohort 2: Child-Pugh Class B | EXPERIMENTAL | Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
| Cohort 3: Child-Pugh Class C | EXPERIMENTAL | Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
| IDX719 + RTV | EXPERIMENTAL | Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14. |
| Simeprevir/TMC647055 + RTV | EXPERIMENTAL | Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14. |
| 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. |
| Group A: IDX719 then IDX719/Simeprevir | EXPERIMENTAL | Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. |
| Group B: Simeprevir then IDX719/Simeprevir | EXPERIMENTAL | Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. |
| Group C: IDX719 | EXPERIMENTAL | Healthy participants take IDX719 150 mg QD on Days 1-14. |
| Group D: IDX719/Simeprevir | EXPERIMENTAL | Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK. |
| Group E: High-Fat then Low-Fat PK | EXPERIMENTAL | Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout). |
| Group F: Low-Fat then High-Fat PK | EXPERIMENTAL | Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout). |
| 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. |
| 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. |
| 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. |
| IDX719 | DRUG | IDX719 supplied as 50 mg tablets. |
| RTV | DRUG | RTV will be supplied as 80 mg/mL solution for oral administration. |
| Omeprazole | DRUG | 40 mg delayed-release oral capsules, once daily |
| Ritonavir | DRUG | 100 mg oral tablets, once daily |
| Placebo | DRUG | Placebo liquid suspension matching IDX719 taken by mouth. |
| 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 antiviral drug being developed by Merck & Company, Inc. (ticker MRK) for the treatment of chronic hepatitis C infection. It is not yet approved and remains in clinical development, with studies conducted in patients with chronic hepatitis C virus and in healthy participants.
Samatasvir is being studied for the treatment of chronic hepatitis C infection and chronic hepatitis C virus. Clinical trials have evaluated it in combination regimens with other antivirals, including simeprevir and TMC647055/ritonavir, with or without ribavirin, in participants with chronic hepatitis C infection.
Samatasvir is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program studying samatasvir in chronic hepatitis C infection, including combination studies with other direct-acting antiviral agents.
Samatasvir is in Phase 1 development and is investigational. Its clinical program includes Phase 1 studies in healthy participants and a Phase 2 combination study in participants with chronic hepatitis C infection. It has not been approved by the FDA for any indication.
Samatasvir has been studied in completed trials including NCT01852604, a Phase 2 combination study in chronic hepatitis C infection with 143 participants, NCT01813552, a Phase 1 drug interaction study in healthy participants, and NCT01335607, a Phase 1 bioavailability and food effect study in healthy male participants.
Yes, samatasvir tablet refers to the same investigational drug as samatasvir. Samatasvir is also known by the development code IDX719, and an earlier related code IDX184 appears in one bioavailability study. All refer to the Merck antiviral program for chronic hepatitis C infection.