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| ID | Type | Description | Link |
|---|---|---|---|
| 47910382HPC1003 | Other Identifier | Janssen R&D Ireland |
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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 (how a drug is absorbed and distributed in the body), and intrinsic antiviral activity of JNJ-47910382 after 5 consecutive days of administration in chronic, hepatitis C virus (HCV)-genotype-1-infected patients at different doses and dose regimens.
This is a double-blind (neither physician nor patient knows the name of the assigned drug), randomized (patients are assigned by chance to treatment groups) placebo-controlled study. A placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. The study population will consist of Asian treatment-naive genotype-1, chronic HCV-infected patients. The trial will involve a screening period at a maximum of 6 weeks before baseline, a 9-day treatment period (with 5 days of actual medication intake) and a 4-week follow-up period. Patients will be divided into 3 panels of 8 patients (Panel 1) or 5 patients (Panels 2 and 3). Treatment will be initiated in each panel of patients sequentially. In each panel, patients will receive JNJ-47910382 or placebo during 5 consecutive days. JNJ-47910382, or placebo, will be administered once daily. Treatments will be taken by mouth and with standardized meals in all dosing regimens. Patient safety will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1 | Experimental | Study participants will receive double-blind treatment with JNJ-47910382 30 mg or matching placebo. Participants in each of Panel will be treated sequentially (ie, participants in Panel 1 will be treated before participants in Panel 2, participants in Panel 2 will be treated before participants in Panel 3). |
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| Panel 2 | Experimental | Study participants will receive double-blind treatment with JNJ-47910382 90 mg or matching placebo. Participants in each of Panel will be treated sequentially. |
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| Panel 3 | Experimental | Study participants will receive double-blind treatment with JNJ-47910382 200 mg (maxiumum dose) or matching placebo. Participants in each of Panel will be treated sequentially. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-47910382 30 mg | Drug | JNJ-47910382 30 mg (0.6 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HCV RNA levels over time during the 5-day treatment regimen | Up to 4 weeks after the last dose of study medication. | |
| Number of participants with HCV RNA levels below the limit of detection | Up to 4 weeks after the last dose of study medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean plasma concentrations of JNJ-47910382 | Up to Day 9 of each treatment period. | |
| Maximum observed plasma concentration of JNJ-47910382 | Up to Day 9 of each treatment period. | |
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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 |
|---|---|---|---|---|---|---|
| Kaohsiung City | Taiwan | |||||
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| JNJ-47910382 90 mg | Drug | JNJ-47910382 90 mg (1.8 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days. |
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| JNJ-47910382 200 mg | Drug | JNJ-47910382 200 mg (4 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days. |
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| Placebo | Drug | Matching Placebo administered once daily as monotherapy for 5 days. |
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| Minimum observed plasma concentration of JNJ-47910382 |
| Up to Day 9 of each treatment period |
| Time to reach the maximum plasma concentration of JNJ-47910382 | Up to Day 9 of each treatment period. |
| Area under the plasma concentration-time curve from time 0 to 24 hours of JNJ-47910382 | Up to Day 9 of each treatment period. |
| Average steady-state plasma concentration of JNJ-47910382 | Up to Day 9 of each treatment period. |
| Terminal elimination half life of JNJ-47910382 | Up to Day 9 of each treatment period. |
| The number of participants affected by an adverse event | Up to 30 days after the last dose of study medication |
| Niaosung, Kaohsiung |
| Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |