A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy participants.

Official Title
-----------------
A Phase I, Double-Blind, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX320 and IDX184 in Healthy Subjects

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: IDX320
* Drug: IDX184
* Drug: IDX184 placebo
* Drug: IDX320 placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To participate in the study, participants must meet the following requirements: Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m2. Must be a non-smoker. Must agree to use an acceptable double-barrier method of birth control. Must provide written informed consent after the study has been fully explained. Exclusion Criteria: Participants are not eligible if they meet any of the following: Pregnant or breastfeeding. History of clinically significant diseases, as determined by the investigator. Safety laboratory abnormalities at screening which are clinically significant. Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV). Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDX320 + PBO → IDX320 + IDX184<br>400 mg IDX320 and IDX184 matching placebo (PBO) once daily for 7 days; followed by 400 mg IDX320 and 100 mg IDX184 once daily for 7 days | Drug: IDX320<br>* IDX320 400 mg in tablets (8x50 mg) administered orally once daily<br>Drug: IDX184<br>* IDX184 100 mg in capsules (2x50 mg) administered orally once daily<br>Drug: IDX184 placebo<br>* IDX184 matching placebo in capsules administered orally once daily<br>|
| Experimental: IDX184 + PBO → IDX184 + IDX320<br>100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days | Drug: IDX320<br>* IDX320 400 mg in tablets (8x50 mg) administered orally once daily<br>Drug: IDX184<br>* IDX184 100 mg in capsules (2x50 mg) administered orally once daily<br>Drug: IDX320 placebo<br>* IDX320 matching placebo in tablets administered orally once daily<br>|
| Placebo Comparator: IDX320 PBO + IDX184 PBO<br>IDX320 matching PBO + IDX184 matching PBO for 14 days | Drug: IDX184 placebo<br>* IDX184 matching placebo in capsules administered orally once daily<br>Drug: IDX320 placebo<br>* IDX320 matching placebo in tablets administered orally once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve at steady state (AUCss) of plasma IDX320 |  | Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose | 
| AUCss of plasma IDX184 |  | Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose | 
| AUCss of plasma 2'-methylguanosine (2'-MeG) |  | Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose | 
| Maximum observed concentration (Cmax) of plasma IDX320 |  | Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose | 
| Cmax of plasma IDX184 |  | Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose | 
| Cmax of plasma 2'-MeG |  | Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose | 
| Trough concentration (Ctrough) of plasma IDX320 |  | Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose | 
| Ctrough of plasma IDX184 |  | Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose | 
| Ctrough of plasma 2-MeG |  | Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an adverse event (AE) |  | Up to Day 19 | 
| Number of participants who discontinued treatment due to an AE |  | Up to Day 14 | 

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