Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.

Official Title
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A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Subjects

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: IDX719
* Drug: Simeprevir
* Drug: TMC647055
* Drug: RTV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 the study drug Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug Exclusion Criteria: Is pregnant or breastfeeding Has another clinically significant medical conditions or laboratory abnormality(s)

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: IDX719 + RTV<br>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. | Drug: IDX719<br>* IDX719 will be supplied as a 50 mg tablet for oral administration.<br>Drug: Simeprevir<br>* Simeprevir will be supplied as 75 mg capsules for oral administration.<br>* Other names: Olysio™;Drug: TMC647055<br>* TMC647055 will be supplied as 150 mg capsules for oral administration.<br>Drug: RTV<br>* RTV will be supplied as 80 mg/mL solution for oral administration.<br>* Other names: Norvir™;|
| Experimental: Simeprevir/TMC647055 + RTV<br>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. | Drug: IDX719<br>* IDX719 will be supplied as a 50 mg tablet for oral administration.<br>Drug: Simeprevir<br>* Simeprevir will be supplied as 75 mg capsules for oral administration.<br>* Other names: Olysio™;Drug: TMC647055<br>* TMC647055 will be supplied as 150 mg capsules for oral administration.<br>Drug: RTV<br>* RTV will be supplied as 80 mg/mL solution for oral administration.<br>* Other names: Norvir™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed maximum plasma drug concentration (Cmax) |  | Up to 14 days | 
| Time to maximum concentration (Tmax) |  | Up to 14 days | 
| Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t) |  | Up to 14 days | 
| Predose trough concentration (Ctrough) |  | Up to 14 days | 
| Apparent terminal elimination rate constant |  | Up to 14 days | 
| Observed terminal half-life (T1/2) |  | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants experiencing serious adverse events (SAEs) |  | Up to 28 days | 
| Percentage of participants experiencing adverse events (AEs) |  | Up to 28 days | 
| Percentage of participants with Grade 1-4 laboratory abnormalities |  | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C, Hepatitis C virus, HCV