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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: IDX719; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Healthy Participants; 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; IDX719 liquid suspension (1 - 100 mg) taken by mouth.; Drug: Placebo; Placebo liquid suspension matching IDX719 taken by mouth.
Experimental: Group B: HCV Participants; 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; IDX719 liquid suspension (1 - 100 mg) taken by mouth.; Drug: Placebo; Placebo liquid suspension matching IDX719 taken by mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Vince B, Hill JM, Lawitz EJ, O'Riordan W, Webster LR, Gruener DM, Mofsen RS, Murillo A, Donovan E, Chen J, McCarville JF, Sullivan-Bolyai JZ, Mayers D, Zhou XJ. A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus genotype 1, 2, 3 or 4. J Hepatol. 2014 May;60(5):920-7. doi: 10.1016/j.jhep.2014.01.003. Epub 2014 Jan 14.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 11, 2012

Study Record Updates

• Last Update Posted (Estimate): April 27, 2015
• Last Update Submitted That Met QC Criteria: April 24, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: HCV; Hepatitis C; treatment-naive
• 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; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: 1894-001; IDX-06A-001 (Other Identifier: Idenix Pharmaceuticals, Inc)