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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02112942

Enrollment

Registered

2014-04-14

Start date

2014-03-31

Completion date

2014-06-30

Last updated

2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C virus, HCV

Brief summary

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.

Interventions

DRUGIDX21459

DRUGMatching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability assessment	up to 35 days	Proportion of subjects experiencing adverse events.

Secondary

Measure	Time frame	Description
Pharmacokinetic	Up to 120 hours post dose	Plasma and urine concentrations of IDX21459 and its metabolite/s.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026