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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects

NCT00807001

Chronic Hepatitis C (HCV)

COMPLETED PHASE1/PHASE2

Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects

NCT01473056

Hepatitis C Virus Infection, Response to Therapy of

COMPLETED PHASE1

Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

NCT02112942

Chronic Hepatitis C

TERMINATED PHASE1

Evaluating the Safety of ITX 5061 in Treatment-Naive Hepatitis C (HCV)-Infected Adults

NCT01165359

Hepatitis C

COMPLETED PHASE1

Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults

NCT00439959

Hepatitis C, Chronic Hepatitis C

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

IDX719

Intervention Type DRUG

IDX719 liquid suspension (1 - 100 mg) taken by mouth.

Placebo

Intervention Type DRUG

Placebo liquid suspension matching IDX719 taken by mouth.

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.

Group Type EXPERIMENTAL

IDX719

Intervention Type DRUG

IDX719 liquid suspension (1 - 100 mg) taken by mouth.

Placebo

Intervention Type DRUG

Placebo liquid suspension matching IDX719 taken by mouth.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IDX719

IDX719 liquid suspension (1 - 100 mg) taken by mouth.

Intervention Type DRUG

Placebo

Placebo liquid suspension matching IDX719 taken by mouth.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes