Hepatitis C Clinical Trial
Official title:
A Multi-center, Placebo-controlled, Multiple Dose, Study of the Safety and Pharmacokinetics and Pharmacodynamics of INX-08189 Dosed Either QD, BID or Adjunctively With Ribavirin, and a Study of the Food Effect, in Chronically-infected Genotype 1 HCV, Treatment-naïve Subjects
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.
Primary Objectives:
To evaluate in chronically-infected, non-cirrhotic, genotype 1 treatment naïve-subjects
dosed with Study Drug for 7 consecutive days
Safety
- The safety of each of the 4 dosing cohorts of INX-08189 (200 mg daily (QD), 100 mg twice a
day (BID), 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin).
Pharmacokinetic
- To characterize the pharmacokinetic (PK) profile of oral doses of INX-08189 (200 mg QD,
100 mg BID, 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin) and the PK
profile of the metabolite (INX-08032).
Pharmacodynamic
- To evaluate the relationship between the kinetics of the reduction from baseline in serum
HCV RNA and PK parameters of INX-08189 and the metabolite INX-08032
Efficacy
- To measure the kinetics of viral load reduction in plasma HCV RNA by each of the 4 dosing
cohorts of INX-08189 (200 mg QD, 100 mg BID, 100 mg QD with low-fat meal, and 100 mg QD with
adjunctive ribavirin).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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