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| ID | Type | Description | Link |
|---|---|---|---|
| 64281802DNG2001 | Other Identifier | Janssen Research & Development, LLC |
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portfolio reprioritization
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The purpose of this study is to assess the antiviral activity of JNJ-64281802 versus placebo in terms of reduction of dengue virus 1 (DENV-1) ribonucleic acid (RNA) viral load (VL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive matching placebo of JNJ-64281802 orally. |
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| JNJ-64281802 High dose | Experimental | Participants will receive high dose of JNJ-64281802 orally. |
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| JNJ-64281802 Medium dose | Experimental | Participants will receive medium dose of JNJ-64281802 orally. |
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| JNJ-64281802 Low dose | Experimental | Participants will receive low dose of JNJ-64281802 orally. |
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| JNJ-64281802 Dosing Regimen X | Experimental | Participants will receive dosing regimen X of JNJ-64281802 orally. |
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| JNJ-64281802 Dosing Regimen Y | Experimental | Participants will receive dosing regimen Y of JNJ-64281802 orally. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29 | Area under the dengue virus (DENV)-1 ribonucleic acid (RNA) Viral Load (VL) concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported. | Baseline to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to Day 85 |
| Number of Participants with Clinically Significant Abnormalities in Physical Examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| JNJ-64281802 Dosing Regimen Z | Experimental | Participants will receive dosing regimen Z of JNJ-64281802 orally. |
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| JNJ-64281802 High dose |
| Drug |
JNJ-64281802 high dose will be administered orally. |
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| JNJ-64281802 Medium dose | Drug | JNJ-64281802 medium dose will be administered orally. |
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| JNJ-64281802 Low dose | Drug | JNJ-64281802 low dose will be administered orally. |
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| JNJ-64281802 Dosing Regimen X | Drug | JNJ-64281802 dosing regimen X will be administered orally. |
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| JNJ-64281802 Dosing Regimen Y | Drug | JNJ-64281802 dosing regimen Y will be administered orally. |
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| JNJ-64281802 Dosing Regimen Z | Drug | JNJ-64281802 dosing regimen Z will be administered orally. |
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Number of participants with clinically significant abnormalities in physical examination will be reported. |
| Up to Day 85 |
| Number of Participants with Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant abnormalities in vital signs (body temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported. | Up to Day 85 |
| Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs) | Number of participants with clinically significant abnormalities in electrocardiogram (ECGs) will be reported. | Up to Day 21 |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, blood coagulation, and urine samples) will be reported. | Up to Day 85 |
| Number of Participants with DENV Infection Associated AEs | Number of participants with DENV infection associated AEs will be reported. | Up to Day 85 |
| Area Under the log10-transformed DENV 1 RNA VL Concentration-time Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29 | Area under the log10-transformed DENV 1 RNA VL concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported. | Baseline to Day 29 |
| Peak of Detectable DENV-1 RNA | Peak of detectable DENV-1 RNA will be reported. | Up to Day 85 |
| Duration of Detectable DENV-1 RNA | Duration of detectable DENV-1 RNA will be reported. | Up to Day 85 |
| Time to First Onset of Detectable DENV-1 RNA | Time to first onset of detectable DENV-1 RNA will be reported. | Up to Day 85 |
| Number of Participants with Detectable DENV-1 RNA | Number of participants with detectable DENV-1 RNA will be reported. | Up to Day 85 |
| Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29 | Area under the viremia curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported. | Baseline to Day 29 |
| Area Under the log10-transformed Viremia Curves | Area under the log10-transformed viremia curves will be reported. | Up to Day 85 |
| Peak of Detectable Viremia Level | Peak of detectable viremia level will be reported. | Up to Day 85 |
| Duration of Detectable Viremia | Duration of detectable viremia will be reported. | Up to Day 85 |
| Time to First Onset of Detectable Viremia | Time to first onset of detectable viremia will be reported. | Up to Day 85 |
| Number of Participants with Detectable Viremia | Number of participants with detectable viremia will be reported. | Up to Day 85 |
| Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802 | Cmax is the maximum observed analyte concentration. | Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours Postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose |
| Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802 | Cmin is the minimum observed analyte concentration. | Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose |
| Trough Plasma Analyte Concentration (Ctrough) of JNJ-64281802 | (Ctrough) is defined as observed analyte concentration just prior to the beginning or at the end of a dosing interval. | Day -4, 1, 6, 8, 10, and 15: Predose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose |
| Average Analyte Concentration (Cavg) of JNJ-64281802 | Cavg is defined as average analyte concentration over the dosing interval (tau) and will be calculated as AUCtau/Tau. | Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose |
| Time to Reach Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-64281802 | Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration. | Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose |
| Fluctuation Index (FI) of JNJ-64281802 | FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg). | Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose |
| Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) | The AUCtau is the measure of the plasma analyte concentration from time zero to end of dosing interval. AUC during a dosing interval (τ), calculated by linear-linear trapezoidal summation. | Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose |
| Number of Participants with Anti DENV-1 Total IgM and IgG Antibody Titers | Anti-DENV-1 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies will be measured using enzyme-linked immunosorbent assay (ELISA). | Up to Day 85 |
| Time to First Onset of Anti-DENV-1 Total IgM and IgG Antibody Titers | Time to first onset of anti-DENV-1 total IgM and IgG antibody titers will be reported. | Up to Day 85 |