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

Phase 1TerminatedNCT02112942

Merck Sharp & Dohme LLC48 enrolled

Overview

A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

IDX21459DRUG

Matching PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: All subjects * Subjects are in good general health. * Subjects have provided written informed consent form. * All subjects of childbearing potential must have agreed 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 the study drug. HCV Subjects * Documented clinical history compatible with chronic hepatitis C without cirrhosis. * Treatment-naïve * HCV Genotype 1 Exclusion Criteria: All subjects * Pregnant or breastfeeding * Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV). * Decompensated liver disease * Other clinically significant medical conditions or laboratory abnormalities.

Outcomes

Primary Outcomes

Safety and tolerability assessment

Proportion of subjects experiencing adverse events.

Time frame: up to 35 days

Secondary Outcomes

Pharmacokinetic

Plasma and urine concentrations of IDX21459 and its metabolite/s.

Time frame: Up to 120 hours post dose

Data from ClinicalTrials.gov

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