Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT01445795
Brief Summary:
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.
Detailed Description:
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).
Study:
NCT01445795
Study Brief:
Protocol Section:
NCT01445795