To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Randomized, Open-label Study to Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of IDX719 in Healthy Subjects

Conditions
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Chronic Hepatitis C Infection

Intervention / Treatment
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* Drug: Samatasvir
* Drug: Omeprazole
* Drug: Ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained. All participants of childbearing potential must agree to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug. Exclusion Criteria: Pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Samatasvir + Ritonavir<br>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. | Drug: Samatasvir<br>* Samatasvir 150 mg oral tablets (50mg x 3), single dose<br>Drug: Ritonavir<br>* 100 mg oral tablets, once daily<br>|
| Experimental: Samatasvir + Omeprazole<br>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. | Drug: Samatasvir<br>* Samatasvir 150 mg oral tablets (50mg x 3), single dose<br>Drug: Omeprazole<br>* 40 mg delayed-release oral capsules, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality |  | Up to 17 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, Hepatitis C, antiviral drugs, liver