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
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1351 Kimberly Rd
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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