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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: Samatasvir tablet; Drug: Samatasvir capsule

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Part A: Samatasvir cap→tab→tab; Part B: cap; 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; Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose); Drug: Samatasvir capsule; Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)
ACTIVE_COMPARATOR: Part A: Samatasvir tab→cap→tab; Part B: cap; 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; Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose); Drug: Samatasvir capsule; Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: April 8, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (ESTIMATE): April 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 26, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: HCV; Hepatitis C Virus
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: 2355-006; IDX-08C-006 (OTHER: Idenix Protocol Number)