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| ID | Type | Description | Link |
|---|---|---|---|
| 64281802DNG2003 | Other Identifier | Janssen Research & Development, LLC |
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Feasibility of enrollment impacted by COVID
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The purpose of this study is to investigate the antiviral activity of JNJ-64281802 versus placebo in terms of reduction of dengue virus (DENV) ribonucleic acid (RNA) in primary DENV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-64281802 | Experimental | Participants will receive 2 initial loading doses of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5. |
|
| Placebo | Placebo Comparator | Participants will receive oral dose of matching placebo every 8 hour (q8h) and once daily on Day 4 and Day 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64281802 | Drug | JNJ-64281802 will be administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Log10-Transformed Dengue Virus (DENV) RiboNucleic Acid (RNA) Viral Load (VL) Curve From Baseline Until Day 5 (AUCD1-D5 [log10VL]). | The antiviral activity of JNJ-64281802 versus placebo in terms of reduction of DENV RNA in participants with a primary DENV infection was planned to be measured by the area under the log10-transformed DENV RNA viral load concentration-time curves from baseline (Day 1) until Day 5 (AUCD1-D5 [log10VL]). | Baseline (Day 1) upto Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (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. TEAEs were those AE events that occurred at or after the initial administration of study intervention through the last onsite visit. |
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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 |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Singapore | 169608 | Singapore |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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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Due to small number of enrolled participants, planned data collection and analysis was not performed for the efficacy objectives and no data was reported for efficacy outcome measures and thus only safety analysis data were reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | JNJ-64281802 | Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5. |
| FG001 | Placebo | Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | JNJ-64281802 | Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5. |
| BG001 | Placebo | Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Log10-Transformed Dengue Virus (DENV) RiboNucleic Acid (RNA) Viral Load (VL) Curve From Baseline Until Day 5 (AUCD1-D5 [log10VL]). | The antiviral activity of JNJ-64281802 versus placebo in terms of reduction of DENV RNA in participants with a primary DENV infection was planned to be measured by the area under the log10-transformed DENV RNA viral load concentration-time curves from baseline (Day 1) until Day 5 (AUCD1-D5 [log10VL]). | Due to the small number of enrolled participants, planned data collection and analysis was not performed and thus no data was reported for this outcome measure. | Posted | Baseline (Day 1) upto Day 5 |
|
From Day 1 up to the last onsite visit (Day 30)
Safety population which included all randomized participants who had taken at least 1 dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JNJ-64281802 | Participants received 2 initial loading dose of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
Since feasibility of enrollment was impacted by COVID, sponsor terminated the study. Due to small number of enrolled participants, planned data collection and analysis was not performed for the efficacy objectives and thus no data was reported for efficacy outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GLOBAL MEDICAL LEADER RESPIRATORY INFEC | Janssen Research & Development, LLC | +12153252489 | ClinicalTrialDisclosure@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2022 | Feb 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2023 | Feb 5, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| Placebo |
| Drug |
Matching placebo (PEG400) will be administered orally. |
|
| From Day 1 up to the last onsite visit (Day 30) |
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | Number of participants with clinically significant abnormalities in ECGs parameters as assessed based on investigator's discretion were reported. | From Day 1 up to the last onsite visit (Day 30) |
| Number of Participants With Clinically Significant Abnormalities in Physical Examination | Number of participants with clinically significant abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) as assessed based on investigator's discretion were reported. | From Day 1 up to the last onsite visit (Day 30) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, peripheral capillary oxygen saturation [spO2], input-output [I/O] ratio and blood pressure) as assessed based on investigator's discretion were reported. | From Day 1 up to the last onsite visit (Day 30) |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, and coagulation) were reported. Clinical significance was defined as per investigator's judgement. | From Day 1 up to the last onsite visit (Day 30) |
| Plasma Concentrations of JNJ-64281802 | Plasma Concentrations of JNJ-64281802 was assessed. Due to small number of enrolled participants, no summary statistics analysis was performed. Participant wise data were reported for this outcome measure. | Predose: 0, 8, 16 hours on Day 1; 24, 32, 40 hours on Day 2; Day 4, Day 5; and Post dose: 4, 12 hours on Day 1; 28, 36 hours on Day 2; 48 hours on Day 3; Day 6, Day 14, Day 21, Day 28 |
| Number of Participants With Occurrence of Detectable Dengue Virus (DENV) RiboNucleic Acid (RNA) in Primary DENV Infection | Number of participants with occurrence of detectable DENV RNA in primary DENV infection was a planned analysis. | Predose: 24 hour on Day 2; Post dose: 12 hour on Day 1; 36 hour on Day 2; Days 3, 4, 5, 6, 7, 8, 9, 14, 21 and 28 |
| Time to Undetectable Dengue Virus (DENV) RiboNucleic Acid (RNA) in Primary DENV Infection | Time to undetectable DENV RNA in primary DENV infection was a planned analysis. | Predose: 24 hour on Day 2; Post dose: 12 hour on Day 1; 36 hour on Day 2; Days 3, 4, 5, 6, 7, 8, 9, 14, 21 and 28 |
| Area Under the Plasma Concentration Time Curve During One Dosing Interval (AUC[Tau]) of JNJ-64281802 | AUC[tau] is defined as area under the plasma concentration time curve during one dosing interval of JNJ-64281802. | 0, 8, 16 hours pre-dose on Day 1; 4 and 12 hours post-dose on Day 1 |
| Trough (Pre-dose) Analyte Concentration (Ctrough) of JNJ-64281802 | Ctrough is defined as plasma concentration just prior to the beginning or at the end of a dosing interval of JNJ-64281802. | Pre-dose on Day 1: 0 hour, 8 hour, 16 hour; pre-dose on Day 2: 24 hour, 32 hour, 40 hour; pre-dose on Day 4 and Day 5 |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802 | Cmax is defined as the maximum observed plasma concentration of JNJ-64281802. | 0, 8, 16 hours pre-dose on Day 1; 4 and 12 hours post-dose on Day 1 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| Placebo |
Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5. |
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (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. TEAEs were those AE events that occurred at or after the initial administration of study intervention through the last onsite visit. | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to the last onsite visit (Day 30) |
|
|
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | Number of participants with clinically significant abnormalities in ECGs parameters as assessed based on investigator's discretion were reported. | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to the last onsite visit (Day 30) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Physical Examination | Number of participants with clinically significant abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) as assessed based on investigator's discretion were reported. | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to the last onsite visit (Day 30) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, peripheral capillary oxygen saturation [spO2], input-output [I/O] ratio and blood pressure) as assessed based on investigator's discretion were reported. | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to the last onsite visit (Day 30) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, and coagulation) were reported. Clinical significance was defined as per investigator's judgement. | Safety population included all randomized participants who had taken at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to the last onsite visit (Day 30) |
|
|
|
| Secondary | Plasma Concentrations of JNJ-64281802 | Plasma Concentrations of JNJ-64281802 was assessed. Due to small number of enrolled participants, no summary statistics analysis was performed. Participant wise data were reported for this outcome measure. | Pharmacokinetic population which included all participants who receive at least 1 dose of study drug and who had at least 1 plasma concentration data value after dosing. Data for this outcome measure was not planned to be collected and analyzed for the placebo arm. | Posted | Number | nanograms per milliliter | Predose: 0, 8, 16 hours on Day 1; 24, 32, 40 hours on Day 2; Day 4, Day 5; and Post dose: 4, 12 hours on Day 1; 28, 36 hours on Day 2; 48 hours on Day 3; Day 6, Day 14, Day 21, Day 28 |
|
|
|
| Secondary | Number of Participants With Occurrence of Detectable Dengue Virus (DENV) RiboNucleic Acid (RNA) in Primary DENV Infection | Number of participants with occurrence of detectable DENV RNA in primary DENV infection was a planned analysis. | Due to small number of enrolled participants, planned data collection and analysis was not performed and thus no data was reported for this outcome measure. | Posted | Predose: 24 hour on Day 2; Post dose: 12 hour on Day 1; 36 hour on Day 2; Days 3, 4, 5, 6, 7, 8, 9, 14, 21 and 28 |
|
|
| Secondary | Time to Undetectable Dengue Virus (DENV) RiboNucleic Acid (RNA) in Primary DENV Infection | Time to undetectable DENV RNA in primary DENV infection was a planned analysis. | Due to small number of enrolled participants, planned data collection and analysis was not performed and thus no data was reported for this outcome measure. | Posted | Predose: 24 hour on Day 2; Post dose: 12 hour on Day 1; 36 hour on Day 2; Days 3, 4, 5, 6, 7, 8, 9, 14, 21 and 28 |
|
|
| Secondary | Area Under the Plasma Concentration Time Curve During One Dosing Interval (AUC[Tau]) of JNJ-64281802 | AUC[tau] is defined as area under the plasma concentration time curve during one dosing interval of JNJ-64281802. | Due to small number of enrolled participants, formal analysis was not performed for the planned PK parameters and thus no data was reported for this outcome measure | Posted | 0, 8, 16 hours pre-dose on Day 1; 4 and 12 hours post-dose on Day 1 |
|
|
| Secondary | Trough (Pre-dose) Analyte Concentration (Ctrough) of JNJ-64281802 | Ctrough is defined as plasma concentration just prior to the beginning or at the end of a dosing interval of JNJ-64281802. | Due to small number of enrolled participants, formal analysis was not performed for the planned PK parameters and thus no data was reported for this outcome measure. | Posted | Pre-dose on Day 1: 0 hour, 8 hour, 16 hour; pre-dose on Day 2: 24 hour, 32 hour, 40 hour; pre-dose on Day 4 and Day 5 |
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802 | Cmax is defined as the maximum observed plasma concentration of JNJ-64281802. | Due to small number of enrolled participants, formal analysis was not performed for the planned PK parameters and thus no data was reported for this outcome measure | Posted | 0, 8, 16 hours pre-dose on Day 1; 4 and 12 hours post-dose on Day 1 |
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|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Placebo | Participants received oral dose of placebo matching to JNJ-64281802 every 8 hour (q8h) and once daily on Day 4 and Day 5. | 0 | 3 | 0 | 3 | 3 | 3 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Epigastric Discomfort | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Gingival Bleeding | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Lymphocyte Count Decreased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Neutrophil Count Decreased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Platelet Count Decreased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dizziness Postural | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
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| Participant 1: Day 1, 8 hr pre-dose |
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| Participant 1: Day 1, 12 hr post-dose |
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| Participant 1: Day 1, 16 hr pre-dose |
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| Participant 1: Day 2, 24 hr pre-dose |
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| Participant 1: Day 2, 28 hr post-dose |
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| Participant 1: Day 2, 32 hr pre-dose |
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| Participant 1: Day 2, 36 hr post-dose |
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| Participant 1: Day 2, 40 hr pre-dose |
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| Participant 1: Day 3, 48 hr post-dose |
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| Participant 1: Day 4, pre-dose |
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| Participant 1: Day 5, pre-dose |
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| Participant 1: Day 6, post-dose |
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| Participant 1: Day 14 post-dose |
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| Participant 1: Day 21 post dose |
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| Participant 1: Day 28 post dose |
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| Participant 2: Day 1, pre-dose |
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| Participant 2: Day 1, 4 hr post-dose |
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| Participant 2: Day 1, 8 hr pre-dose |
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| Participant 2: Day 1, 12 hr post-dose |
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| Participant 2: Day 1, 16 hr pre-dose |
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| Participant 2: Day 2, 24 hr pre-dose |
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| Participant 2: Day 2, 28 hr post-dose |
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| Participant 2: Day 2, 32 hr pre-dose |
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| Participant 2: Day 2, 36 hr post-dose |
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| Participant 2: Day 2, 40 hr pre-dose |
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| Participant 2: Day 3, 48 hr post-dose |
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| Participant 2: Day 4, pre-dose |
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| Participant 2: Day 5, pre-dose |
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| Participant 2: Day 6, post-dose |
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| Participant 2: Day 14 post-dose |
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| Participant 2: Day 21 post dose |
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| Participant 2: Day 28 post dose |
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