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| ID | Type | Description | Link |
|---|---|---|---|
| 47910382HPC1002 | Other Identifier | Janssen R&D Ireland | |
| 2011-005110-10 | EudraCT Number |
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Because of many competing trials using the same mechanism of action, but being further advanced in development
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel I | Experimental | Patients will be randomized to receive JNJ-47910382 at a dose of 30 mg or placebo as monotherapy once daily for 5 days. |
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| Panel II | Experimental | Patients will be randomized to receive JNJ-47910382 at a dose of 90 mg or placebo as monotherapy once daily for 5 days. |
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| Panel III | Experimental | Patients will be randomized to receive JNJ-47910382 at a dose of 300 mg or placebo as monotherapy once daily for 5 days. |
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| Panel IV | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Form=suspension, route=oral. |
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| Measure | Description | Time Frame |
|---|---|---|
| Determination of pharmacokinetics of JNJ-47910382 | The pharmacokinetics of JNJ-47910382 after 5 consecutive days of administration in chronic HCV-genotype-1 infected patients in different doses and dose regimens will be determined. | Up to 9 Days |
| Evaluation of the intrinsic antiviral activity of JNJ-47910382 | Evaluation of the intrinsic antiviral activity of different doses and dose regimens of JNJ-47910382 in chronic HCV-genotype-1 infected subjects, as measured by the HCV RNA decrease from baseline (Day 1) over time. | Up to 4 weeks |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen R&D Ireland Clinical Trial | Janssen R&D Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamburg | Germany | |||||
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| JNJ-47910382 | Drug | Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral. Study drug will be administered once or twice daily |
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| Kiel |
| Germany |
| Mainz | Germany |
| Münster | Germany |
| Tübingen | Germany |
| Ulm | Germany |