Trial Outcomes & Findings for A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus (NCT NCT03333317)
NCT ID: NCT03333317
Last Updated: 2019-12-23
Results Overview
AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab.
TERMINATED
PHASE2
7 participants
Day 1 to 7: Predose, 0.25 and 2 hours postdose
2019-12-23
Participant Flow
On 17 October 2018, the study was stopped prematurely by the sponsor as a precautionary measure, to allow further evaluation and assessment of the new nonclinical pharmacokinetics (PK) and safety findings and determine their relevance to human studies.
Total 7 participants were randomized to receive lumicitabine or placebo.
Participant milestones
| Measure |
Placebo
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
3
|
|
Overall Study
COMPLETED
|
3
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16 months
STANDARD_DEVIATION 13.08 • n=5 Participants
|
17 months
n=7 Participants
|
6.3 months
STANDARD_DEVIATION 2.52 • n=5 Participants
|
12 months
STANDARD_DEVIATION 9.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
JAPAN
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 7: Predose, 0.25 and 2 hours postdosePopulation: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. All AEs reported during treatment or follow-up were considered emergent and were included in the analysis.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants With Emergent Adverse Event
|
3 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Randomized or Treated set was defined as all participants who were in Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or all participants treated (AST) set.
The number of participants with clinically significant physical examination (respiratory system, nose, ear, throat, facial and neck lymph nodes, and skin examination) abnormalities that emerged after treatment initiation was reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examinations Abnormalities
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.
The number of participants with emergent clinically relevant vital signs (temperature, pulse rate, respiratory rate, diastolic blood pressure, systolic blood pressure, oxygen saturation) abnormalities that emerged after treatment initiation reported. An abnormality was considered emergent in a particular phase if it is worse than baseline. If baseline is missing, the abnormality is always considered as emergent. A shift from 'abnormally low' at baseline to 'abnormally high' post baseline (or vice versa) was also emergent.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
Systolic Blood Pressure (Abnormally high)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
Diastolic Blood Pressure (Abnormally high)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
Pulse Rate (Abnormally high)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
Temperature (High)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
Oxygen Saturation (Abnormally low)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
Respiratory Rate (Abnormally high)
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.
The number of participants with ECG (QT, and QTc intervals) abnormalities reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QT Duration
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcB: Bazett's Correction Formula
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcF: Fridericia's Correction Formula
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.
Number of participants with Laboratory (hematology, serum chemistry, and urinalysis) abnormalities reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 0 is normal and not meeting the criteria of Grade 1-4. Hb: Grade 1: for 22-35 days old- 9.5-10.5 gram per deciliter (g/dL); for 36-60 days old- 8.5-9.4 g/dL; for 61-90 days old- 9.0-9.9 g/dL; Hb: Grade 2: for 22-35 days old- 8.0-9.4 g/dL, for 36-60 days old- 7.0-8.4 g/dL; for 61-90 days old- 7.0-8.9 g/dL. ALT: Grade 1- 1.1 - \<2.0\*Upper limit of normal (ULN); Creatinine: Grade 2- 1.8-2.4 milligram per deciliter (mg/dL); Hyperkalemia: Grade 1- 3.0-3-5 milliequivalents per Liter (mEq/L); ANC: Grade 1: for 7-60 days old- 1200-1800/ millimeter cube(mm\^3); for 61-90 days old- 750-1200/mm\^3; ANC: Grade 3: for 7-60 days old- 500-899/mm\^3, for 61-90 days old- 250-399/mm\^3; ANC: Grade 4- for 7-60 days old \<500/mm\^3, for 61-90 days old- \<250/mm\^3; Platelets: Grade 3: 25000 - 49999/mm\^3.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Alanine transaminase (ALT): Grade 0
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
ALT: Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Aspartate Aminotransferase (AST): Grade 0
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Bilirubin: Grade 0
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Creatinine: Grade 0
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Creatinine: Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hypoglycemia: Grade 0
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hyperglycemia: Grade 0
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hypokalemia: Grade 0
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hyperkalemia: Grade 1
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hemoglobin (Hb): Grade 0
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hb: Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Absolute neutrophil count (ANC): Grade 0
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
ANC: Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
ANC: Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
ANC: Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Platelets: Grade 0
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hyperkalemia: Grade 0
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hyponatremia: Grade 0
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hypernatremia: Grade 0
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Hb: Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Platelets: Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 5Population: Intent to Treat (ITT) set was defined as all randomized participants who receive at least 1 dose of study.
Cmax is the maximum observed plasma concentration of JNJ-63549109 (Metabolite of Lumicitabine).
Outcome measures
| Measure |
Placebo
n=1 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine)
Day 1
|
6184 nanogram/milliliter (ng/ml)
|
7003 nanogram/milliliter (ng/ml)
Standard Deviation 3806
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine)
Day 5
|
3261 nanogram/milliliter (ng/ml)
|
5112 nanogram/milliliter (ng/ml)
Standard Deviation 1665
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 5Population: ITT set was defined as all randomized participants who receive at least 1 dose of study.
AUC is the area under the plasma concentration-time curve of JNJ-63549109 (Metabolite of Lumicitabine).
Outcome measures
| Measure |
Placebo
n=1 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine)
Day 1
|
12700 nanogram hour per milliliters (ng*h/ml)
|
17800 nanogram hour per milliliters (ng*h/ml)
Standard Deviation 713.9
|
—
|
|
Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine)
Day 5
|
11840 nanogram hour per milliliters (ng*h/ml)
|
20500 nanogram hour per milliliters (ng*h/ml)
Standard Deviation 655.7
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 5Population: ITT set was defined as all randomized participants who receive at least 1 dose of study.
C(trough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen of JNJ-63549109 (Metabolite of Lumicitabine).
Outcome measures
| Measure |
Placebo
n=1 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine)
Day 1
|
91.16 ng/ml
|
187.8 ng/ml
Standard Deviation 52.97
|
—
|
|
Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine)
Day 5
|
189.8 ng/ml
|
358.3 ng/ml
Standard Deviation 37.42
|
—
|
SECONDARY outcome
Timeframe: 12 hours postdosePopulation: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
C12h is the predicted concentration of JNJ-63549109 at 12 hours Postdose. C12h is a model-based prediction. It was determined using a population pharmacokinetic (PK) model and based on the individual model predicted concentration-time profiles.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Population included randomized or treated set. As the study was early terminated with fewer participants than planned, results for this endpoint could not be summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.
Length of hospital stay is defined as the time from hospitalization to actual hospital discharge.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Length of Hospital Stay
Participant 1
|
143.5 Hours
|
—
|
—
|
|
Length of Hospital Stay
Participant 2
|
167.8 Hours
|
—
|
—
|
|
Length of Hospital Stay
Participant 3
|
179.4 Hours
|
—
|
—
|
|
Length of Hospital Stay
Participant 4
|
—
|
167.8 Hours
|
—
|
|
Length of Hospital Stay
Participant 5
|
—
|
—
|
120 Hours
|
|
Length of Hospital Stay
Participant 6
|
—
|
—
|
239.5 Hours
|
|
Length of Hospital Stay
Participant 7
|
—
|
—
|
149.3 Hours
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
Number of participants who were admitted to the ICU was reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants Admitted to the Intensive Care Unit (ICU)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: No participant was admitted to ICU hence results could not be determined for this outcome measure.
In the event that a participant required ICU, the duration for how long the participant remained in the ICU was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
The number of participants who required supplemental oxygen above pre-RSV infection status was reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants Who Required Supplemental Oxygen
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
The number of participants who required non-invasive mechanical ventilation support (that is, continuous positive airway pressure) above pre-RSV infection status was reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants Who Required Non-invasive Mechanical Ventilation Support
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
The number of participants who required invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-RSV infection status was reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants Who Required Invasive Mechanical Ventilation Support
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Population included randomized or treated set who received supplemental oxygen.
Duration of supplemental oxygen above pre-RSV infection status was assessed.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Duration of Supplemental Oxygen
|
59.4 Hours
|
0.5 Hours
|
—
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: No participant received non-invasive mechanical ventilation support hence results could not be drawn for this outcome measure.
Duration of non-invasive mechanical ventilation support (that is, continuous positive airway pressure) to deliver oxygen above pre-RSV infection status was measured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: No participant received invasive mechanical ventilation support hence results could not be drawn for this outcome measure.
Duration of invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) to deliver oxygen above pre-RSV infection status was measured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Population included randomized or treated set who received supplemental oxygen.
Time to no longer requiring supplemental oxygen above pre-RSV infection status was reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Time to no Longer Requiring Supplemental Oxygen
|
59.4 Hours
|
0.5 Hours
|
—
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Population included randomized or treated set. Due to early study termination and less number of participants collected data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.
Time to clinical stability was defined as the time at which the following criteria are all met: normalization of blood oxygen level (return to baseline, by pulse oximetry) without the requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Time to Clinical Stability
Participant 7
|
—
|
—
|
0 Hours
|
|
Time to Clinical Stability
Participant 1
|
63.8 Hours
|
—
|
—
|
|
Time to Clinical Stability
Participant 2
|
39.5 Hours
|
—
|
—
|
|
Time to Clinical Stability
Participant 3
|
191.2 Hours
|
—
|
—
|
|
Time to Clinical Stability
Participant 4
|
—
|
63.3 Hours
|
—
|
|
Time to Clinical Stability
Participant 5
|
—
|
—
|
71.3 Hours
|
|
Time to Clinical Stability
Participant 6
|
—
|
—
|
646.4 Hours
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
Time from initiation of study treatment until SpO2 \>=93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Population included randomized or treated set. As study was terminated early with fewer participants than planned, results for this endpoint could not be summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.
Time for the respiratory rate to return to pre-RSV infection status was measured.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Participant 1
|
0 Hours
|
—
|
—
|
|
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Participant 2
|
39.5 Hours
|
—
|
—
|
|
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Participant 3
|
46.4 Hours
|
—
|
—
|
|
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Participant 4
|
—
|
0 Hours
|
—
|
|
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Participant 5
|
—
|
—
|
71.3 Hours
|
|
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Participant 6
|
—
|
—
|
646.4 Hours
|
|
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Participant 7
|
—
|
—
|
0 Hours
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Population included randomized or treated set. As study was terminated early with fewer participants than planned, data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.
Time for SpO2 to return to pre-RSV infection status was measured.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Time for SpO2 to Return to Pre-RSV Infection Status
Participant 1
|
0 Hours
|
—
|
—
|
|
Time for SpO2 to Return to Pre-RSV Infection Status
Participant 2
|
0 Hours
|
—
|
—
|
|
Time for SpO2 to Return to Pre-RSV Infection Status
Participant 3
|
70 Hours
|
—
|
—
|
|
Time for SpO2 to Return to Pre-RSV Infection Status
Participant 4
|
—
|
33.7 Hours
|
—
|
|
Time for SpO2 to Return to Pre-RSV Infection Status
Participant 5
|
—
|
—
|
0 Hours
|
|
Time for SpO2 to Return to Pre-RSV Infection Status
Participant 6
|
—
|
—
|
0 Hours
|
|
Time for SpO2 to Return to Pre-RSV Infection Status
Participant 7
|
—
|
—
|
0 Hours
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Population included randomized or treated set. As study was terminated early with fewer participants than planned, data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.
Time for body temperature to return to pre-RSV infection status was measured.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Time for Body Temperature to Return To Pre-RSV Infection Status
Participant 7
|
—
|
—
|
641.6 Hours
|
|
Time for Body Temperature to Return To Pre-RSV Infection Status
Participant 1
|
0 Hours
|
—
|
—
|
|
Time for Body Temperature to Return To Pre-RSV Infection Status
Participant 2
|
643.5 Hours
|
—
|
—
|
|
Time for Body Temperature to Return To Pre-RSV Infection Status
Participant 3
|
37.4 Hours
|
—
|
—
|
|
Time for Body Temperature to Return To Pre-RSV Infection Status
Participant 4
|
—
|
16.7 Hours
|
—
|
|
Time for Body Temperature to Return To Pre-RSV Infection Status
Participant 5
|
—
|
—
|
0 Hours
|
|
Time for Body Temperature to Return To Pre-RSV Infection Status
Participant 6
|
—
|
—
|
0 Hours
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
Number of participants with acute otitis media was reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants With Acute Otitis Media
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
Duration of signs and symptoms of RSV infection was assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
The severity of signs and symptoms of RSV infection were assessed by the PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3 and the total score was analyzed by summing up the individual score ranging from 0 (minimum; best) to 15 (maximum; worse).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Day 2, 3, 4, 5, 6, 7, 10, 14 and 28Population: Intention-To-Treat-infected (ITT-i) set was defined as all randomly assigned participants who receive at least 1 dose of study drug and who have an RSV infection confirmed by a polymerase chain reaction (PCR)-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory.
RSV viral load over time was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
RSV Viral Load Over Time
Day 2
|
5.817 log10 per milliliters (log10/mL)
Standard Deviation 2.2087
|
6.809 log10 per milliliters (log10/mL)
|
6.660 log10 per milliliters (log10/mL)
Standard Deviation 0.9732
|
|
RSV Viral Load Over Time
Day 3
|
5.443 log10 per milliliters (log10/mL)
Standard Deviation 1.4645
|
6.000 log10 per milliliters (log10/mL)
|
5.351 log10 per milliliters (log10/mL)
Standard Deviation 0.5794
|
|
RSV Viral Load Over Time
Day 7
|
2.994 log10 per milliliters (log10/mL)
Standard Deviation 1.4450
|
4.584 log10 per milliliters (log10/mL)
|
2.754 log10 per milliliters (log10/mL)
Standard Deviation 1.2688
|
|
RSV Viral Load Over Time
Day 10
|
2.821 log10 per milliliters (log10/mL)
Standard Deviation 1.5950
|
1.900 log10 per milliliters (log10/mL)
|
3.573 log10 per milliliters (log10/mL)
Standard Deviation 0.7610
|
|
RSV Viral Load Over Time
Day 14
|
1.900 log10 per milliliters (log10/mL)
Standard Deviation 0.0000
|
2.900 log10 per milliliters (log10/mL)
|
1.983 log10 per milliliters (log10/mL)
Standard Deviation 0.1443
|
|
RSV Viral Load Over Time
Day 4
|
4.674 log10 per milliliters (log10/mL)
Standard Deviation 2.4209
|
2.900 log10 per milliliters (log10/mL)
|
4.190 log10 per milliliters (log10/mL)
Standard Deviation 1.4190
|
|
RSV Viral Load Over Time
Day 5
|
3.808 log10 per milliliters (log10/mL)
Standard Deviation 1.0049
|
5.949 log10 per milliliters (log10/mL)
|
4.521 log10 per milliliters (log10/mL)
Standard Deviation 1.7506
|
|
RSV Viral Load Over Time
Day 6
|
3.137 log10 per milliliters (log10/mL)
Standard Deviation 1.9306
|
6.514 log10 per milliliters (log10/mL)
|
4.110 log10 per milliliters (log10/mL)
Standard Deviation 1.6980
|
|
RSV Viral Load Over Time
Day 28
|
1.900 log10 per milliliters (log10/mL)
Standard Deviation 0.0000
|
1.900 log10 per milliliters (log10/mL)
|
1.900 log10 per milliliters (log10/mL)
Standard Deviation 0.0000
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
Peak viral load was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
Time to peak viral load was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: ITT-i set was defined as all randomly assigned participants who receive at least 1 dose of study drug and who have an RSV infection confirmed by a PCR-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory.
Percentage of participants with decline in viral load during treatment as measured by qRT-PCR was reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Percentage of Participants With Decline of Viral Load
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
Time to RSV RNA being undetectable (the time from initiation of study treatment until the time at which it is observed that the virus is undetectable in an assessment and after which time no virus positive assessment follows) was assessed as measured by qRT-PCR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
Percentage of participants with the undetectable viral load was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 10Population: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
AUC of RSV RNA viral load was measured in mid-turbinate nasal swabs and in the endotracheal sample.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 14Population: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
AUC of RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline Until 1 Day after the last dose of study drug (up to 10 days)Population: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
AUC of RSV viral load was measured in midturbinate nasal swabs and in endotracheal samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 28 daysPopulation: Randomized or Treated set was defined as all participants who were in Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or all participants treated (AST) set.
Number of participants with emergent postbaseline changes in the RSV polymerase L-gene and other regions of the RSV genome compared with baseline sequences were reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 Participants
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Number of Participants With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 6Population: As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.
Acceptability and Palatability of lumicitabine formulation was assessed by clinician eCOA questionnaire ranging from score 0 (minimum; best) to 8 (maximum; worse).
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Lumicitabine 40/20 mg/kg LD/MD
Lumicitabine 60/40 mg/kg LD/MD
Serious adverse events
| Measure |
Placebo
n=3 participants at risk
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 participants at risk
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 participants at risk
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
33.3%
1/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
Other adverse events
| Measure |
Placebo
n=3 participants at risk
Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
|
Lumicitabine 40/20 mg/kg LD/MD
n=1 participants at risk
Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 participants at risk
Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
66.7%
2/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
33.3%
1/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
33.3%
1/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
100.0%
1/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
|
Infections and infestations
Pharyngitis
|
33.3%
1/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
|
Infections and infestations
Pneumonia Bacterial
|
33.3%
1/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
33.3%
1/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/1 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
0.00%
0/3 • Up to 28 days
Safety analysis set included all participants who received at least 1 dose of drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER