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Study of the Safety & PK of INX-08189 in Chronically-infected HCV, Treatment-naïve Subjects

NCT01250366 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2012-07-12

No results posted yet for this study

Summary

The purpose of this study is to determine the Safety and Pharmacokinetics of Multiple Ascending Oral Doses of INX-08189 in Chronically-infected Genotype 1 HCV, Treatment-naïve Subjects.

Conditions

  • HCV (Genotype 1)

Interventions

DRUG

INX-08189

Capsules, Oral, 9 mg, Once Daily, 7 Days

DRUG

INX-08189

Capsule, Oral, 25 mg, Once Daily, 7 days

DRUG

INX-08189

Capsules, Oral, 50 mg, Single Dose, 1 day

DRUG

INX-08189

Capsules, Oral, 9 mg, Once daily, 6 days

DRUG

INX-08189

Capsules, Oral, 50 mg, Once daily, 7 days

DRUG

INX-08189

Capsules, Oral, 9 mg, Once daily, 7 days

DRUG

INX-08189

Capsules, Oral, 100 mg, Once daily, 7 days

DRUG

Placebo matching with INX-08189

Capsules, Oral, 0 mg, Once daily, 7 days

DRUG

Ribavirin

Capsules, Oral, 1000 or 1200 mg daily (delivered in weight-adjusted am/pm divided dose), 7 days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-03-31
Completion
2011-06-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01250366 on ClinicalTrials.gov