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 |
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
1351 Kimberly Rd
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
(563) 355-7733

Hematology Oncology Associates of the Quad Cities
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
