Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)

Study Overview
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Brief Summary
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The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.

Official Title
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A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: IDX719
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Participants Is in good general health. Agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs. HCV Participants Has documented GT1, GT2, or GT3 chronic HCV infection. Exclusion Criteria: All Participants Is pregnant or breastfeeding. HCV Participants Has received prior HCV treatment. Is co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Healthy Participants<br>Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses. | Drug: IDX719<br>* IDX719 liquid suspension (1 - 100 mg) taken by mouth.<br>Drug: Placebo<br>* Placebo liquid suspension matching IDX719 taken by mouth.<br>|
| Experimental: Group B: HCV Participants<br>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. | Drug: IDX719<br>* IDX719 liquid suspension (1 - 100 mg) taken by mouth.<br>Drug: Placebo<br>* Placebo liquid suspension matching IDX719 taken by mouth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants experiencing an adverse event (AE) |  | Up to 14 days | 
| Percentage of participants experiencing serious AEs (SAEs) |  | Up to 14 days | 
| Change in HCV ribonucleic acid (RNA) |  | Baseline and Day 10 | 
| Maximum plasma drug concentration (Cmax) |  | Pre-dose Day 1 to Day 13 | 
| Time to maximum plasma drug concentration (Tmax) |  | Pre-dose Day 1 to Day 13 | 
| Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t) |  | Pre-dose Day 1 to Day 13 | 
| AUC from time zero to time 24 hours (AUC0-24h) |  | Pre-dose Day 1 to Day 1 | 
| AUC from time zero to time infinity (AUC0- ) |  | Pre-dose Day 1 to Day 13 | 
| Pre-dose trough plasma drug concentration (Ctrough) |  | Pre-dose Day 1 | 
| Observed terminal plasma drug concentration half-life (t1/2) |  | Pre-dose Day 1 to Day 13 | 
| Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-  (single dose) or Dose/AUC0-t (multiple doses) |  | Pre-dose Day 1 to Day 13 | 
| Apparent oral total volume of distribution (Vz/F) |  | Pre-dose Day 1 to Day 13 | 
| Amount excreted in urine in each collection interval (Au) |  | Pre-dose Day 1 to Day 14 | 
| Cumulative urine excretion (Au0-t) |  | Pre-dose Day 1 to Day 14 | 
| Percentage of dose excreted in urine (% Dose excr) |  | Pre-dose Day 1 to Day 14 | 
| Renal clearance (CLr) |  | Pre-dose Day 1 to Day 14 | 
| Percentage of participants experiencing dose-limiting toxicity |  | Up to 8 days | 
| Percentage of participants experiencing graded laboratory abnormalities |  | Up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, HCV, treatment-naive