Trial Outcomes & Findings for Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus (NCT NCT02935673)

Results Overview

Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Day 1

Results posted on

2019-12-24

Participant Flow

Sponsor halted screening and enrollment in study on 22 June 2018 due to emerging lumicitabine nonclinical data. On 17 October 2018, study was stopped prematurely by sponsor as a precautionary measure, to allow further evaluation of new nonclinical pharmacokinetic (PK) and safety findings and determine their relevance to human studies.

A total of 49 participants were randomized and treated (2 participants in Part 0, 36 participants in Part 1 and 11 participants in Part 2). Analyses were conducted on pooled groups across the 3 study parts.

Participant milestones

Participant milestones
Measure	Placebo Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	750 mg LD / 250 mg MD Lumicitabine Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Overall Study STARTED	16	27	6
Overall Study COMPLETED	15	24	6
Overall Study NOT COMPLETED	1	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	750 mg LD / 250 mg MD Lumicitabine Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	1	2	0

Baseline Characteristics

Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=16 Participants Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	750 mg LD / 250 mg MD Lumicitabine n=27 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=6 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	Total n=49 Participants Total of all reporting groups
Age, Continuous	65.5 years STANDARD_DEVIATION 17.94 • n=5 Participants	66.3 years STANDARD_DEVIATION 17.75 • n=7 Participants	68.7 years STANDARD_DEVIATION 18.46 • n=5 Participants	66.3 years STANDARD_DEVIATION 17.54 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	18 Participants n=7 Participants	1 Participants n=5 Participants	30 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	25 Participants n=7 Participants	6 Participants n=5 Participants	45 Participants n=4 Participants
Ethnicity (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 (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	4 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	18 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	12 Participants n=5 Participants	14 Participants n=7 Participants	3 Participants n=5 Participants	29 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	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment ARGENTINA	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment AUSTRALIA	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment FRANCE	1 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment JAPAN	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment MALAYSIA	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment POLAND	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment SOUTH KOREA	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment SPAIN	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment SWEDEN	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment TAIWAN	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment UNITED KINGDOM	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment UNITED STATES	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic (PK) analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=26 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=4 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1	1845 nanogram per milliliter (ng/mL) Standard Deviation 545.2	2801 nanogram per milliliter (ng/mL) Standard Deviation 1509	—

PRIMARY outcome

Timeframe: Day 5

Population: PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=22 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=2 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5	745.4 ng/mL Standard Deviation 164.2	1145 ng/mL Standard Deviation 440.8	—

PRIMARY outcome

Timeframe: Day 1

Population: PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

AUC(0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=26 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=4 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1	9936 nanogramhour per milliliter (ngh/mL) Standard Deviation 2090	17120 nanogramhour per milliliter (ngh/mL) Standard Deviation 4330	—

PRIMARY outcome

Timeframe: Day 5

Population: PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

AUC(0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=22 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=2 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5	7557 ng*h/mL Standard Deviation 1525	13300 ng*h/mL Standard Deviation 4603	—

PRIMARY outcome

Timeframe: Day 1

Population: PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=26 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=4 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1	93.7 ng/mL Standard Deviation 44.16	184.4 ng/mL Standard Deviation 70.66	—

PRIMARY outcome

Timeframe: Day 5

Population: PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=22 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=2 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5	148.3 ng/mL Standard Deviation 60.41	281.3 ng/mL Standard Deviation 156.6	—

PRIMARY outcome

Timeframe: Day 1 (Baseline) to 7

Population: Intent-to-treat-infected (ITT-i) set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

RSV RNA viral load in log10 copies/milliliter/day (log10 copies/mL/day) was measured in mid-turbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling methods) using quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Due to early termination of study, the analysis was not conducted as planned. Instead, using the same specification as for the primary analysis, a comparison was made on the AUC(1-7) days of pooled active treatment groups versus pooled placebo. The comparison was done as planned using a mixed model for repeated measures, using all available viral load data of baseline up to and including Day 7. The model computes the AUC at group level based on all available data, taking missing data into account under the missing at random assumption. The table reports the planned difference versus (pooled) placebo. No adjustment for multiplicity was applied.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7]) Day 2	-0.3 log10 copies/mL/day Interval -0.9 to 0.3	-1.4 log10 copies/mL/day Interval -2.0 to -0.9	-2.5 log10 copies/mL/day Interval -3.6 to -1.3
Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7]) Day 3	-1.4 log10 copies/mL/day Interval -2.1 to -0.7	-1.9 log10 copies/mL/day Interval -2.5 to -1.2	-1.9 log10 copies/mL/day Interval -3.4 to -0.5
Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7]) Day 4	-2.1 log10 copies/mL/day Interval -2.8 to -1.4	-2.2 log10 copies/mL/day Interval -2.8 to -1.6	-1.8 log10 copies/mL/day Interval -3.2 to -0.5
Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7]) Day 5	-2.5 log10 copies/mL/day Interval -3.2 to -1.9	-2.5 log10 copies/mL/day Interval -3.1 to -1.9	-1.3 log10 copies/mL/day Interval -2.6 to -0.1
Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7]) Day 6	-2.5 log10 copies/mL/day Interval -3.2 to -1.7	-2.7 log10 copies/mL/day Interval -3.3 to -2.0	-3.1 log10 copies/mL/day Interval -4.5 to -1.7
Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7]) Day 7	-2.8 log10 copies/mL/day Interval -3.5 to -2.0	-2.8 log10 copies/mL/day Interval -3.5 to -2.2	-3.3 log10 copies/mL/day Interval -4.5 to -2.0

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Analyses were conducted on pooled groups across the 3 study parts.

An 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.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=16 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=27 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=6 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants With Adverse Events (AEs)	7 Participants	22 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants with vital sign (systolic and diastolic blood pressure \[BP\], pulse rate, respiratory rate, temperature and oxygen saturation) abnormalities were reported. For systolic BP: abnormally low refers to less than or equal to (\<=) 90 millimeter of mercury (mmHg); for diastolic BP: abnormally low refers to \<= 50 mmHg; for pulse rate abnormally low refers to less than (\<) 45 beats per minutes (bpm) and abnormally high refers to greater than or equal to (\>=) 120 bpm; for temperature in degree Celsius abnormally high refers to greater than (\>) 37.8 (tympanic), \>38.0 (forehead), \>38.0 (oral), \>37.2 (rectal), \>38.0 (axillary); for oxygen saturation in percentage (%) abnormally low refers to \< 95. Grade 1 = mild; grade 2 = moderate; grade 3 = severe.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=16 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=27 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=6 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants With Vital Sign Abnormalities Systolic BP (Abnormally low)	1 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Systolic BP (Grade 1 or mild)	2 Participants	6 Participants	2 Participants
Number of Participants With Vital Sign Abnormalities Systolic BP (Grade 2 or moderate)	5 Participants	4 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Systolic BP (Grade 3 or severe)	1 Participants	1 Participants	1 Participants
Number of Participants With Vital Sign Abnormalities Diastolic BP (Abnormally low)	2 Participants	1 Participants	1 Participants
Number of Participants With Vital Sign Abnormalities Diastolic BP (Grade 1 or mild)	5 Participants	8 Participants	1 Participants
Number of Participants With Vital Sign Abnormalities Diastolic BP (Grade 2 or moderate)	3 Participants	1 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Diastolic BP (Grade 3 or severe)	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Pulse Rate (Abnormally high)	2 Participants	1 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Respiratory Rate (Grade 1 or mild)	2 Participants	0 Participants	1 Participants
Number of Participants With Vital Sign Abnormalities Respiratory Rate (Grade 2 or moderate)	4 Participants	6 Participants	1 Participants
Number of Participants With Vital Sign Abnormalities Respiratory Rate (Grade 3 or severe)	3 Participants	2 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Temperature (Abnormally high)	4 Participants	2 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Oxygen Saturation (Abnormally low)	7 Participants	9 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants with QT interval abnormalities (prolonged) were reported.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=24 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants With QT Interval Abnormalities	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants with clinical laboratory (serum chemistry and hematology) abnormalities were reported. Abbreviations; Erythrocyte MCHC = Erythrocyte Mean Corpuscular Hemoglobin Concentration; Erythrocyte MCH = Erythrocyte Mean Corpuscular Hemoglobin; Ery. = Erythrocyte

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=16 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=27 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=6 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants With Clinical Laboratory Abnormalities Direct Bilirubin : High	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Bicarbonate : Low	0 Participants	2 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Bicarbonate: High	3 Participants	5 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Chloride : Low	0 Participants	3 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Chloride : High	0 Participants	2 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Creatine Kinase : Low	4 Participants	2 Participants	3 Participants
Number of Participants With Clinical Laboratory Abnormalities Creatine Kinase ; High	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Indirect Bilirubin : Low	1 Participants	0 Participants	2 Participants
Number of Participants With Clinical Laboratory Abnormalities Basophils : High	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Eosinophils : High	3 Participants	1 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Erythrocytes MCHC : Low	1 Participants	1 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Erythrocytes MCH : Low	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Erythrocytes MCH : High	0 Participants	3 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Erythrocytes : Low	5 Participants	3 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Ery. Distribution Width : Low	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Ery. Distribution Width : High	2 Participants	5 Participants	3 Participants
Number of Participants With Clinical Laboratory Abnormalities Hematocrit : Low	4 Participants	5 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Hematocrit : High	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Lymphocytes : Low	0 Participants	4 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Lymphocytes : High	4 Participants	3 Participants	2 Participants
Number of Participants With Clinical Laboratory Abnormalities Monocyte : Low	0 Participants	2 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Monocyte : High	5 Participants	5 Participants	3 Participants
Number of Participants With Clinical Laboratory Abnormalities Reticulocytes : Low	0 Participants	1 Participants	2 Participants
Number of Participants With Clinical Laboratory Abnormalities Reticulocytes : High	4 Participants	2 Participants	4 Participants
Number of Participants With Clinical Laboratory Abnormalities Reticulocytes/Erythrocytes : Low	1 Participants	0 Participants	1 Participants
Number of Participants With Clinical Laboratory Abnormalities Reticulocytes/Erythrocytes : High	4 Participants	9 Participants	3 Participants

SECONDARY outcome

Timeframe: From study treatment initiation to discharge (Up to 28 Days)

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

It is the time from treatment initiation to hospital discharge in hours.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time of Hospital Stay From Study Treatment Initiation to Discharge	183.91 Hours Standard Deviation 217.020	146.72 Hours Standard Deviation 94.910	405.24 Hours Standard Deviation 294.771

SECONDARY outcome

Timeframe: From admission to discharge (Up to 28 Days)

Population: Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

It is the time from hospital admission to hospital discharge in hours.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=10 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=17 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=3 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time of Hospital Stay From Admission to Discharge	192.40 Hours Standard Deviation 199.363	181.97 Hours Standard Deviation 107.938	297.53 Hours Standard Deviation 348.729

SECONDARY outcome

Timeframe: From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

It is the time from study treatment initiation to readiness for discharge in hours, with readiness for discharge defined by the investigator.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge	111.05 Hours Standard Deviation 78.237	144.17 Hours Standard Deviation 96.019	197.60 Hours Standard Deviation 256.702

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

It is the time from hospital admission to readiness for discharge in hours, with readiness for discharge defined by the investigator.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=10 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=17 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=3 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time of Hospital Stay From Admission to Readiness for Discharge	133.41 Hours Standard Deviation 83.057	178.82 Hours Standard Deviation 108.522	297.13 Hours Standard Deviation 349.159

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants who required to be admitted to the ICU since initiation of treatment were reported.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Overall number of participants analyzed is 0, since none of the participants were admitted to ICU since initiation of treatment.

In the event that a participant required ICU since initiation of treatment, the duration for how long the participant remained in the ICU was measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants who required supplemental oxygen were reported.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants Who Required Supplemental Oxygen	14 Participants	18 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Population included ITT-i set who required supplemental oxygen. Analyses were conducted on pooled groups across the 3 study parts.

It is the time from first dose of study drug to the last end date and time of any oxygen supplementation in hours.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=14 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=18 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=4 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time to End of Oxygen Supplementation	83.92 Hours Standard Deviation 168.125	139.38 Hours Standard Deviation 237.584	132.40 Hours Standard Deviation 288.568

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Data was not collected and analyzed because this study was stopped prematurely.

Time (number of hours) 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 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

It is the time from first dose of study drug until the time to return to pre-RSV disease level for respiratory rate. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate	64.72 Hours Standard Deviation 180.542	47.75 Hours Standard Deviation 153.293	196.96 Hours Standard Deviation 290.694

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

It is the time from first dose of study drug until the time to return to pre-RSV disease level for oxygen saturation. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time to Return to Pre-RSV Disease Level for Oxygen Saturation	55.55 Hours Standard Deviation 85.915	33.85 Hours Standard Deviation 57.703	47.56 Hours Standard Deviation 106.347

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Data was not collected and analyzed because this study was stopped prematurely.

It is the time from first dose of study drug until the time to return to pre-RSV disease level for body temperature. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants who required noninvasive mechanical ventilation support (that is supplemental oxygen \[excluding mechanical ventilation\]) were reported.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants Who Required Noninvasive Mechanical Ventilation Support	14 Participants	18 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Population included ITT-i set who required noninvasive mechanical ventilation support. Analyses were conducted on pooled groups across the 3 study parts.

It is the time from first dose of study drug to the last end date and time of noninvasive mechanical ventilation support in hours.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=14 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=18 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=4 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time to End of Noninvasive Mechanical Ventilation Support	83.92 Hours Standard Deviation 168.125	139.38 Hours Standard Deviation 237.584	132.40 Hours Standard Deviation 288.568

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants who required invasive mechanical ventilation support were reported.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants Who Required Invasive Mechanical Ventilation Support	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Overall number of participants analyzed is zero, since none of the participants required mechanical ventilation support.

It is the time from first dose of study drug to the last end date and time of invasive mechanical ventilation support in hours.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

It is the time from first dose of study drug until the time to return to pre-RSV functional status. Functional status is the total points on the KATZ index of independence in activities of daily living (KATZ ADL score). Katz activities of daily living assessed questions related to bathing, dressing, toileting, transferring, continence and feeding components. Total score was calculated by adding the scores for all 6 activities which ranges from 0 high (participant independent) to 6 low (participant very dependent). If one or more component was missing, then the KATZ ADL score was not calculated. The return to pre-RSV functional status occurs at the timepoint where for the first time the KATZ ADL score is equal or higher than the pre-RSV KATZ ADL score and after which no scores lower than the pre-RSV KATZ ADL score occur anymore.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score	3.60 Days Standard Deviation 7.434	4.48 Days Standard Deviation 6.961	6.00 Days Standard Deviation 11.203

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants who required hydration or feeding by IV catheter or nasogastric tube were reported.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube	3 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

Time to clinical stability is defined as the time from first dose of study drug until the time at which the following criteria were all met: normalization of blood oxygen level (return to baseline; by pulse oximetry) without requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate and normalization of heart rate.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Time to Clinical Stability	151.21 Hours Standard Deviation 266.460	171.74 Hours Standard Deviation 261.384	207.00 Hours Standard Deviation 282.955

SECONDARY outcome

Timeframe: Day 5/6 (Day of last study treatment)

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants in each ordinal scale category were reported. Ordinal scale consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered: category 1) death; category 2) admitted to ICU; category 3) non-ICU hospitalization requiring supplemental oxygen; category 4) non-ICU hospitalization not requiring supplemental oxygen; category 5) not hospitalized, unable to resume normal activities; category 6) not hospitalized, resumption of normal activities.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants in Each Ordinal Scale Category Category 5	5 Participants	2 Participants	1 Participants
Number of Participants in Each Ordinal Scale Category Category 6	2 Participants	5 Participants	2 Participants
Number of Participants in Each Ordinal Scale Category Category 1	0 Participants	0 Participants	0 Participants
Number of Participants in Each Ordinal Scale Category Category 2	0 Participants	1 Participants	0 Participants
Number of Participants in Each Ordinal Scale Category Category 3	2 Participants	5 Participants	1 Participants
Number of Participants in Each Ordinal Scale Category Category 4	6 Participants	8 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Analyses were conducted on pooled groups across the 3 study parts.

All-cause mortality included all deaths of participants due to any cause.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=16 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=27 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=6 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants With All-Cause Mortality	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6, 7, 10, 14, and 28

Population: Analysis was performed on ITT-i set. Here 'n' (number analyzed) signifies number of participants evaluable for each time point. Analyses were conducted on pooled groups across the 3 study parts.

Antiviral activity RSV RNA viral load was measured in mid-turbinate nasal swabs (obtained from non-intubated participants) or in mid-turbinate nasal swabs and endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling methods) using qRT-PCR performed at the central laboratory.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
RSV RNA Viral Load Over Time Day 4	4.0608 log10 copies/mL Standard Deviation 1.57493	3.9345 log10 copies/mL Standard Deviation 1.64600	4.0729 log10 copies/mL Standard Deviation 1.15419
RSV RNA Viral Load Over Time Day 2	5.9257 log10 copies/mL Standard Deviation 1.95951	4.7208 log10 copies/mL Standard Deviation 1.60154	3.4242 log10 copies/mL Standard Deviation 1.10867
RSV RNA Viral Load Over Time Day 3	4.8255 log10 copies/mL Standard Deviation 1.84651	4.3515 log10 copies/mL Standard Deviation 1.97633	4.3129 log10 copies/mL Standard Deviation 0.99078
RSV RNA Viral Load Over Time Day 5	3.6463 log10 copies/mL Standard Deviation 1.44056	3.6206 log10 copies/mL Standard Deviation 1.71515	4.5344 log10 copies/mL Standard Deviation 0.97473
RSV RNA Viral Load Over Time Day 6	3.6996 log10 copies/mL Standard Deviation 1.98383	3.4313 log10 copies/mL Standard Deviation 1.57700	3.2163 log10 copies/mL Standard Deviation 1.30083
RSV RNA Viral Load Over Time Day 7	3.4044 log10 copies/mL Standard Deviation 1.75773	3.2306 log10 copies/mL Standard Deviation 1.58432	2.6147 log10 copies/mL Standard Deviation 0.89779
RSV RNA Viral Load Over Time Day 10	2.5966 log10 copies/mL Standard Deviation 1.04644	2.7516 log10 copies/mL Standard Deviation 1.72825	2.5792 log10 copies/mL Standard Deviation 1.00954
RSV RNA Viral Load Over Time Day 14	2.3605 log10 copies/mL Standard Deviation 1.00220	2.3010 log10 copies/mL Standard Deviation 1.03732	2.1512 log10 copies/mL Standard Deviation 0.50236
RSV RNA Viral Load Over Time Day 28	1.9179 log10 copies/mL Standard Deviation 0.06682	1.9714 log10 copies/mL Standard Deviation 0.22559	1.9000 log10 copies/mL Standard Deviation 0.00000

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Data was not collected and analyzed because this study was stopped prematurely.

Peak Viral load is the highest value of log10 viral load at or after the baseline measurement. Peak viral load over time was measured by qRT-PCR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Data was not collected and analyzed because this study was stopped prematurely.

Time to peak viral load is the time from initiation of study treatment until the first time point with the peak viral load.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Data was not collected and analyzed because this study was stopped prematurely.

Rate of decline of viral load over the first 24 hours calculated as a log decline/24 hours defined as: 24-hour log viral load after first dose of study drug minus (-) log viral load at baseline divided by (/) date/time of 24-hour viral load sample - date/time of baseline viral load.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 Days

Population: Data was not collected and analyzed because this study was stopped prematurely.

It is the time in hours from initiation of study treatment until the first post baseline time point at which the virus is undetectable in an assessment and after which time no detectable virus assessment follows as measured by qRT-PCR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 Days

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants with undetectable viral load up to 28 days were reported.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=15 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=21 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=5 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants With Undetectable Viral Load	14 Participants	19 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Day 14

Population: Data was not collected and analyzed because this study was stopped prematurely.

RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 Day after the last dose of study drug

Population: ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. No participant received extended treatment, therefore data was not analyzed.

RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 28 Days

Population: Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.

Number of participants with postbaseline changes in the RSV polymerase L gene and other regions of the RSV genome compared with baseline sequences were reported.

Outcome measures

Outcome measures
Measure	750 mg LD / 250 mg MD Lumicitabine n=10 Participants Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=12 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=4 Participants Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Number of Participants With 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

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

750 mg LD / 250 mg MD Lumicitabine

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

1000 mg LD / 500 mg MD Lumicitabine

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=16 participants at risk Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	750 mg LD / 250 mg MD Lumicitabine n=27 participants at risk Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=6 participants at risk Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Blood and lymphatic system disorders Pancytopenia	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Cardiac disorders Cardiac Failure	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/16 • Up to 28 Days	3.7% 1/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Infections and infestations Influenza	0.00% 0/16 • Up to 28 Days	3.7% 1/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Infections and infestations Pneumonia	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Injury, poisoning and procedural complications Thermal Burn	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/16 • Up to 28 Days	3.7% 1/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • Up to 28 Days	3.7% 1/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days

Other adverse events

Other adverse events
Measure	Placebo n=16 participants at risk Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	750 mg LD / 250 mg MD Lumicitabine n=27 participants at risk Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).	1000 mg LD / 500 mg MD Lumicitabine n=6 participants at risk Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
Blood and lymphatic system disorders Eosinophilia	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/16 • Up to 28 Days	7.4% 2/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • Up to 28 Days	3.7% 1/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Gastritis	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
General disorders Asthenia	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
General disorders Chest Pain	12.5% 2/16 • Up to 28 Days	7.4% 2/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
General disorders Oedema Peripheral	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
General disorders Pyrexia	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Hepatobiliary disorders Hepatic Function Abnormal	0.00% 0/16 • Up to 28 Days	7.4% 2/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Infections and infestations Acarodermatitis	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Infections and infestations Respiratory Tract Infection Bacterial	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Infections and infestations Urinary Tract Infection	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Injury, poisoning and procedural complications Overdose	6.2% 1/16 • Up to 28 Days	11.1% 3/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Investigations Alanine Aminotransferase Increased	6.2% 1/16 • Up to 28 Days	7.4% 2/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Investigations Aspartate Aminotransferase Increased	0.00% 0/16 • Up to 28 Days	3.7% 1/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/16 • Up to 28 Days	7.4% 2/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Investigations Blood Fibrinogen Increased	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Investigations C-Reactive Protein Increased	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Investigations Eosinophil Count Increased	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Investigations Gamma-Glutamyltransferase Increased	6.2% 1/16 • Up to 28 Days	3.7% 1/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Investigations Hepatic Enzyme Increased	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Investigations Occult Blood Positive	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Metabolism and nutrition disorders Hyperglycaemia	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/16 • Up to 28 Days	7.4% 2/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Nervous system disorders Headache	0.00% 0/16 • Up to 28 Days	7.4% 2/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Nervous system disorders Somnolence	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Psychiatric disorders Insomnia	12.5% 2/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Renal and urinary disorders Nephrolithiasis	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Renal and urinary disorders Renal Impairment	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/16 • Up to 28 Days	7.4% 2/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Skin and subcutaneous tissue disorders Acne	6.2% 1/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Skin and subcutaneous tissue disorders Erythema	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Skin and subcutaneous tissue disorders Haemorrhage Subcutaneous	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/16 • Up to 28 Days	7.4% 2/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Skin and subcutaneous tissue disorders Rash	6.2% 1/16 • Up to 28 Days	11.1% 3/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Vascular disorders Deep Vein Thrombosis	0.00% 0/16 • Up to 28 Days	0.00% 0/27 • Up to 28 Days	16.7% 1/6 • Up to 28 Days
Vascular disorders Hypertension	6.2% 1/16 • Up to 28 Days	3.7% 1/27 • Up to 28 Days	0.00% 0/6 • Up to 28 Days

Additional Information

Medical Leader

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

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