HCV (Genotype 1) Clinical Trial
Official title:
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
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment