Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)

Study Overview
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Brief Summary
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The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.

Official Title
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A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Subjects

Conditions
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Chronic Hepatitis C Infection

Intervention / Treatment
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* Drug: IDX719
* Drug: Simeprevir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG) Agrees 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 study drug Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study Exclusion Criteria: Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies Is pregnant or breastfeeding Has previously received either IDX719 or simeprevir Has participated in another clinical drug study within 30 days of Screening

Ages Eligible for Study
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Minimum Age: 18 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: Group A: IDX719 then IDX719/Simeprevir<br>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. | Drug: IDX719<br>* 50 mg tablet for oral administration<br>* Other names: Samatasvir;Drug: Simeprevir<br>* 150 mg capsule for oral administration<br>* Other names: Olysio™;|
| Experimental: Group B: Simeprevir then IDX719/Simeprevir<br>Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. | Drug: IDX719<br>* 50 mg tablet for oral administration<br>* Other names: Samatasvir;Drug: Simeprevir<br>* 150 mg capsule for oral administration<br>* Other names: Olysio™;|
| Experimental: Group C: IDX719<br>Healthy participants take IDX719 150 mg QD on Days 1-14. | Drug: IDX719<br>* 50 mg tablet for oral administration<br>* Other names: Samatasvir;|
| Experimental: Group D: IDX719/Simeprevir<br>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. | Drug: IDX719<br>* 50 mg tablet for oral administration<br>* Other names: Samatasvir;Drug: Simeprevir<br>* 150 mg capsule for oral administration<br>* Other names: Olysio™;|
| Experimental: Group E: High-Fat then Low-Fat PK<br>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). | Drug: IDX719<br>* 50 mg tablet for oral administration<br>* Other names: Samatasvir;|
| Experimental: Group F: Low-Fat then High-Fat PK<br>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). | Drug: IDX719<br>* 50 mg tablet for oral administration<br>* Other names: Samatasvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss) |  | Up to 30 days | 
| Maximum observed plasma concentration (Cmax) |  | Up to 30 days | 
| AUC from time zero to infinity |  | Up to 30 days | 
| Trough plasma concentration (Ctrough) |  | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants experiencing serious adverse events (SAEs) |  | Up to 30 days | 
| Percentage of participants experiencing adverse events (AEs) |  | Up to 30 days | 
| Percentage of participants experiencing Grade 1-4 laboratory abnormalities |  | Up to 30 days | 

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