Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)
NCT01508156 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2015-04-27
Summary
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.
Conditions
- Hepatitis C, Chronic
Interventions
- DRUG
-
IDX719
IDX719 liquid suspension (1 - 100 mg) taken by mouth.
- DRUG
-
Placebo liquid suspension matching IDX719 taken by mouth.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2012-07-31
- Completion
- 2012-07-31
More Related Trials
-
A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)
NCT01593735 ·Status: COMPLETED ·Phase: PHASE1
-
Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)
NCT00730431 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-3281 in Healthy and Hepatitis C Infected Male Participants (MK-3281-002)
NCT00635804 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)
NCT01930058 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)
NCT02161510 ·Status: COMPLETED ·Phase: PHASE1
-
Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)
NCT00518622 ·Status: COMPLETED ·Phase: PHASE1
-
Oral Administration of Anti-CD3 Monoclonal Antibody in Non-responder Genotype-I Chronic Hepatitis C Subjects
NCT01459419 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)
NCT02269059 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.
NCT00671671 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects
NCT01827657 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)
NCT01813513 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
NCT02392494 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study in Hepatitis C Patients With PHN121
NCT01052090 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)
NCT01554189 ·Status: TERMINATED ·Phase: PHASE1
-
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
NCT00314054 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of JNJ-47910382 at Different Doses and Dose Regimens in Asian Genotype-1, Chronic, HCV-Infected Patients
NCT01586325 ·Status: TERMINATED ·Phase: PHASE1
-
Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382
NCT01651767 ·Status: TERMINATED ·Phase: PHASE1
-
Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)
NCT01329913 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002)
NCT01532973 ·Status: COMPLETED ·Phase: PHASE1
-
A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients.
NCT01277692 ·Status: COMPLETED ·Phase: PHASE1
-
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
NCT01181024 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)
NCT01011166 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of MDX-1106 to Treat Patients With Hepatitis C Infection
NCT00703469 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)
NCT01770223 ·Status: WITHDRAWN ·Phase: PHASE4
-
Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
NCT00623649 ·Status: COMPLETED ·Phase: PHASE1