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



Status:Archived
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2010

Use our guide to learn which trials are right for you!

A Multi-center, Sequential-cohort, Placebo-controlled, 7-day Treatment Period Study of the Safety and Pharmacokinetics of Multiple Ascending Oral Doses of INX-08189 in Chronically-infected Genotype 1 HCV, Treatment-naïve Subjects


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.


This is a multi-center, sequential-cohort, double-blind, placebo-controlled, multiple
ascending dose, 7-day treatment study in chronically-infected genotype 1 HCV,
treatment-naïve subjects.

Primary Objectives include:

Safety

• to evaluate the safety of ascending oral doses of INX-08189 given once a day for seven (7)
days in chronically-infected genotype 1 HCV, treatment-naïve subjects

Pharmacokinetic

• to characterize the pharmacokinetic (PK) profile of multiple ascending oral doses of
INX-08189 in chronically-infected genotype 1 HCV, treatment-naïve subjects

Pharmacodynamic

• to evaluate the relationship between the metrics of the reduction from baseline in serum
HCV RNA and PK parameters of INX-08189 and the metabolite INX-08032

Efficacy

• to measure the maximal reduction in plasma HCV RNA by ascending oral dose level of
INX-08189 given once a day for seven (7) days in chronically-infected genotype 1 HCV,
treatment-naïve subjects


We found this trial at
3
sites
Austin, Texas
?
mi
from
Austin, TX
Click here to add this to my saved trials
1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
?
mi
from
Bettendorf, IA
Click here to add this to my saved trials
Santa Clara, California 95051
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials