A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006)

Study Overview
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Brief Summary
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The purpose of this study is to: Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation) Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting. Determine the amount of study drug that is in the blood after eating a meal. Evaluate the safety of the tablet form of samatasvir in healthy people.

Detailed Description
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Each participant will receive each of the formulations in a crossover design. Part A Periods 1 and 2: Participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants will receive samatasvir tablets under fed conditons on Day 15. Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive samatasvir capsules under fed conditons on Day 1.

Official Title
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A Phase I, Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Samatasvir tablet
* Drug: Samatasvir capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be a healthy male with body mass index (BMI) between 18 and 35 kg/m 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: 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
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part A: Samatasvir cap→tab→tab; Part B: cap<br>Part A: Samatasvir capsule as a single dose on Day 1 (fasting state) followed by samatasvir tablet as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) | Drug: Samatasvir tablet<br>* Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)<br>Drug: Samatasvir capsule<br>* Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)<br>|
| Active Comparator: Part A: Samatasvir tab→cap→tab; Part B: cap<br>Part A: Samatasvir tablet as a single dose on Day 1 (fasting state) followed by samatasvir capsule as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) | Drug: Samatasvir tablet<br>* Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)<br>Drug: Samatasvir capsule<br>* Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter: Observed maximum plasma drug concentration (Cmax) |  | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | 
| Pharmacokinetic parameter: Time to maximum concentration (Tmax) |  | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | 
| Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to last measurable concentration (AUC 0-t) |  | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | 
| Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to 24 hours (AUC 0-24) |  | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours | 
| Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to infinity (AUC 0-infinity) |  | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | 
| Pharmacokinetic parameter: Plasma concentration at 24 hours post dose (C24h) |  | 24 hours | 
| Pharmacokinetic parameter: Observed plasma terminal half-life (T1/2) |  | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | 
| Pharmacokinetic parameter: Apparent oral total plasma clearance (CL/F) |  | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | 
| Pharmacokinetic parameter: Apparent oral total plasma volume of distribution (Vz/F) |  | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who experienced an adverse event |  | Up to Day 20 | 
| Percentage of participants who experienced a serious adverse event |  | Up to Day 20 | 
| Percentage of participants who experienced a Grade 1-4 laboratory abnormality |  | Up to Day 20 | 

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