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Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects

NCT01445795 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-06-27

No results posted yet for this study

Summary

This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV), Treatment-naïve subjects.

Conditions

  • Hepatitis C

Interventions

DRUG

200 mg INX-08189 Fasted

200 mg capsule INX-08189 fasted x7 days

DRUG

Placebo QD Fasted

Placebo capsule QD fasted x7 days

DRUG

100 mg INX-08189 QD

100 mg INX-08189 capsule QD x 7 days

DRUG

Placebo QD

Placebo capsule Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID)

DRUG

100 mg INX-08189 with low-fat meal

INX-08189 100 mg capsule, with low-fat meal QD for seven days

DRUG

Placebo with low-fat meal

Placebo capsule administered with a low-fat meal QD for seven days

DRUG

100 mg INX-08189 BID Fasted

100 mg INX-08189 BID fasted x7 days

DRUG

Placebo BID Fasted

Placebo BID fasted x7 days

DRUG

ribavirin

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
2011-09-30
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT01445795 on ClinicalTrials.gov