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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5
JNJ-64281802 will be administered orally.
Matching placebo (PEG400) will be administered orally.
Singapore General Hospital
Singapore, Singapore
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 \[log10VL\]).
Time frame: Baseline (Day 1) upto Day 5
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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 up to the last onsite visit (Day 30)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0, 8, 16 hours pre-dose on Day 1; 4 and 12 hours post-dose on Day 1