Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: Placebo; Drug: JNJ-47910382

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651767

47910382HPC1002 (Other Identifier)

CR100760

2011-005110-10 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (what the body does to the medication) and antiviral activity of JNJ-47910382 when administered in different dosing regimens in Caucasian genotype-1 chronic HCV-infected patients.

Full description

This is a Phase Ib, double-blind (neither physician nor patient knows the treatment that the patient receives), randomized (the study drug is assigned by chance), placebo-controlled study in treatment-naïve (someone who has never used drugs for HCV infection), Caucasian genotype 1 chronic HCV-infected patients. The study consists of a screening period, a 9-day treatment period (with 5 days of actual medication intake) and a 4-week follow-up period. The patients will be divided over 4 panels of 10 patients each that will be initiated sequentially. In each panel patients will receive JNJ-47910382 or placebo during 5 consecutive days. JNJ-47910382 or placebo will be administered once daily or twice daily. Within each panel, 5 patients of genotype-1a and 5 patients of genotype-1b will be enrolled. Patients will be randomly assigned to receive active treatment or placebo in such a way that 4 patients of each genotype receive active treatment and 1 subject of each genotype receives placebo. The pharmacokinetic profile of JNJ-47910382 will be assessed in each panel. HCV RNA kinetics (HCV RNA level) and HCV resistance will be studied and biomarkers at the messenger RNA (mRNA), protein and cell level will be explored. The entire study duration for each participant will be approximately four weeks.

Enrollment: 11 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic (diagnosis of hepatitis C more than or 6 months before the screening period) HCV infection. Geno- and subtype should be determined or confirmed at screening, and should be 1a or 1b
• Never received (Peg) IFN, RBV or any other approved or investigational antiviral treatment for chronic HCV infection
• HCV RNA level of >100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)
• Patients having good accessible veins

Exclusion criteria

• Evidence of liver cirrhosis or decompensated liver disease
• Patient coinfected with HIV-1 or HIV-2, or hepatitis A or B virus infection, or active tuberculosis at study screening
• Patient infected/coinfected with non-genotype-1 HCV at study screening
• Patient with any cardiac disease at screening, or any active clinically significant disease, or medical history or physical examination findings during screening
• Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, thyroid disease or disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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11 participants in 4 patient groups

Panel I

Experimental group

Description:

Patients will be randomized to receive JNJ-47910382 at a dose of 30 mg or placebo as monotherapy once daily for 5 days.

Treatment:

Drug: Placebo

Drug: JNJ-47910382

Panel II

Experimental group

Description:

Patients will be randomized to receive JNJ-47910382 at a dose of 90 mg or placebo as monotherapy once daily for 5 days.

Treatment:

Drug: Placebo

Drug: JNJ-47910382

Panel III

Experimental group

Description:

Patients will be randomized to receive JNJ-47910382 at a dose of 300 mg or placebo as monotherapy once daily for 5 days.

Treatment:

Drug: Placebo

Drug: JNJ-47910382

Panel IV

Experimental group

Description:

Patients will be randomized to receive JNJ-47910382 at a dose of 400 or 450 mg once daily or 300 mg twice daily (morning dose only on Day 5) or placebo as monotherapy for 5 days.

Treatment:

Drug: Placebo

Drug: JNJ-47910382