Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)

A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Subjects

The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C Infection
• Intervention / Treatment: Drug: IDX719; Drug: Simeprevir

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: 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:

• Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
• Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of study drug
• Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study

Exclusion Criteria:

• Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
• Is pregnant or breastfeeding
• Has previously received either IDX719 or simeprevir
• Has participated in another clinical drug study within 30 days of Screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: IDX719 then IDX719/Simeprevir; Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.	Drug: IDX719; 50 mg tablet for oral administration; Other Names: Samatasvir; Drug: Simeprevir; 150 mg capsule for oral administration; Other Names: Olysio™
Experimental: Group B: Simeprevir then IDX719/Simeprevir; Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.	Drug: IDX719; 50 mg tablet for oral administration; Other Names: Samatasvir; Drug: Simeprevir; 150 mg capsule for oral administration; Other Names: Olysio™
Experimental: Group C: IDX719; Healthy participants take IDX719 150 mg QD on Days 1-14.	Drug: IDX719; 50 mg tablet for oral administration; Other Names: Samatasvir
Experimental: Group D: IDX719/Simeprevir; Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK.	Drug: IDX719; 50 mg tablet for oral administration; Other Names: Samatasvir; Drug: Simeprevir; 150 mg capsule for oral administration; Other Names: Olysio™
Experimental: Group E: High-Fat then Low-Fat PK; Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout).	Drug: IDX719; 50 mg tablet for oral administration; Other Names: Samatasvir
Experimental: Group F: Low-Fat then High-Fat PK; Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout).	Drug: IDX719; 50 mg tablet for oral administration; Other Names: Samatasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)	Up to 30 days
Maximum observed plasma concentration (Cmax)	Up to 30 days
AUC from time zero to infinity	Up to 30 days
Trough plasma concentration (Ctrough)	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants experiencing serious adverse events (SAEs)	Up to 30 days
Percentage of participants experiencing adverse events (AEs)	Up to 30 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities	Up to 30 days

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: March 14, 2013
• First Posted (Estimate): March 19, 2013

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; liver; Hepatitis C Virus; antiviral drugs
• 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, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Protease Inhibitors; Simeprevir
• Other Study ID Numbers: 1894-004; IDX-06A-004 (Other Identifier: Idenix Protocol Number)