Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)

Study Overview
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Brief Summary
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The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.

Official Title
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A Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IDX184 After Oral Administration in Healthy Subjects

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: IDX184
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are in general good health. All participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control Exclusion Criteria: Participant is 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDX184 5 mg<br>Healthy participants will be administered a single 5 mg dose of IDX184. | Drug: IDX184<br>* IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.<br>|
| Experimental: IDX184 10 mg<br>Healthy participants will be administered a single 10 mg dose of IDX184. | Drug: IDX184<br>* IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.<br>|
| Experimental: IDX184 25 mg<br>Healthy participants will be administered a single 25 mg dose of IDX184. | Drug: IDX184<br>* IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.<br>|
| Experimental: IDX184 50 mg<br>Healthy participants will be administered a single 50 mg dose of IDX184. | Drug: IDX184<br>* IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.<br>|
| Experimental: IDX184 75 mg<br>Healthy participants will be administered a single 75 mg dose of IDX184. | Drug: IDX184<br>* IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.<br>|
| Experimental: IDX184 100 mg<br>Healthy participants will be administered a single 100 mg dose of IDX184. | Drug: IDX184<br>* IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.<br>|
| Placebo Comparator: Placebo<br>Healthy participants will be administered placebo matching IDX184. | Drug: Placebo<br>* Placebo supplied as size 3, white opaque capsules matching IDX184 capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants experiencing serious adverse events (SAEs) |  | Up to Day 6 | 
| Percentage of participants experiencing AEs |  | Up to Day 6 | 
| Percentage of participants experiencing dose-limiting toxicity (DLTs) |  | Up to Day 6 | 
| Percentage of participants experiencing grade 1-4 laboratory abnormalities |  | Up to Day 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, healthy volunteers