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

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02935673
• Collaborator: (none)
• Enrollment: 49
• Locations: 110
• Arms: 3
• Actual Duration (Months): 20.7
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK model derived from healthy volunteers in hospitalized adults who are infected with respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with respiratory syncytial virus (RSV) infection the dose response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Viruses	Drug: lumicitabine; Drug: Placebo	Phase 2

Detailed Description

The study will be conducted in 3 phases: a screening phase, a treatment phase from Day 1 to Day 5/6 (depending on the timing of the loading dose), and a follow-up phase for a total of 28 days post randomization. Participants will have assessments completed at Day 7, Day 10, Day 14, and Day 28. Depending on discharge date, assessments will be completed either while hospitalized or during outpatient visits. The duration of the participant's participation will be approximately 28 days. The study will be performed in 2 parts. Participants will be randomly assigned to one of 2 treatment groups in part 1, and to one of 3 treatment groups in part 2. Treatment groups will be evaluated for PK and safety after a target of approximately 24 participants have been enrolled in part 1 and before initiating part 2 (approximately 90 participants in part 2). An Independent Data Monitoring Committee (IDMC) will be established to monitor the safety of participants and will review data in an unblinded manner on a regular basis to ensure the continuing safety of the participants enrolled in this study and to evaluate whether efficacy objectives are met. The committee will meet periodically to review interim data. Based on the recommendations of the IDMC following interim analyses/reviews, an increase in duration may be implemented.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Subjects Hospitalized With Respiratory Syncytial Virus
• Actual Study Start Date: Oct 25, 2016
• Actual Primary Completion Date: Jul 17, 2018
• Actual Study Completion Date: Jul 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regimen A (Placebo) Participants of part 1 and part 2 will receive a single loading dose (LD) (Dose 1) followed by 9 maintenance doses (MDs) (Doses 2 to 10) of matching placebo, administered twice daily.	Drug: Placebo; Oral administration of matching placebo.
Experimental: Regimen B (low-dose lumicitabine) Participants of part 1 and part 2 will receive a single 750 mg LD (Dose 1) followed by nine 250 mg MDs (Doses 2 to 10) of lumicitabine, administered twice daily.	Drug: lumicitabine; Oral administration of lumicitabine as tablet.; Other Names: ALS-8176/JNJ-64041575
Experimental: Regimen C (High-dose lumicitabine) Participants of part 2 will receive a single 1000 mg LD (Dose 1) followed by nine 500 mg MDs (Doses 2 to 10) of lumicitabine, administered twice daily.	Drug: lumicitabine; Oral administration of lumicitabine as tablet.; Other Names: ALS-8176/JNJ-64041575

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1 [Day 1]

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

2. Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5 [Day 5]

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

3. Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1 [Day 1]

   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.

4. Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5 [Day 5]

   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.

5. Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1 [Day 1]

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

6. Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5 [Day 5]

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

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 1 (Baseline) to 7]

   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.

Secondary Outcome Measures

1. Number of Participants With Adverse Events (AEs) [Up to 28 Days]

   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.

2. Number of Participants With Vital Sign Abnormalities [Up to 28 Days]

   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.

3. Number of Participants With QT Interval Abnormalities [Up to 28 Days]

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

4. Number of Participants With Clinical Laboratory Abnormalities [Up to 28 Days]

   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

5. Time of Hospital Stay From Study Treatment Initiation to Discharge [From study treatment initiation to discharge (Up to 28 Days)]

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

6. Time of Hospital Stay From Admission to Discharge [From admission to discharge (Up to 28 Days)]

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

7. Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge [From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged]

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

8. Time of Hospital Stay From Admission to Readiness for Discharge [Up to 28 Days]

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

9. Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment [Up to 28 Days]

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

10. Duration of Intensive Care Unit Stay [Up to 28 Days]

    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.

11. Number of Participants Who Required Supplemental Oxygen [Up to 28 Days]

    Number of participants who required supplemental oxygen were reported.

12. Time to End of Oxygen Supplementation [Up to 28 Days]

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

13. Time (Number of Hours) Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=) 93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to the Onset of Respiratory Symptoms [Up to 28 Days]

    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.

14. Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate [Up to 28 Days]

    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.

15. Time to Return to Pre-RSV Disease Level for Oxygen Saturation [Up to 28 Days]

    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.

16. Time to Return to Pre-RSV Disease Level for Body Temperature [Up to 28 Days]

    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.

17. Number of Participants Who Required Noninvasive Mechanical Ventilation Support [Up to 28 Days]

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

18. Time to End of Noninvasive Mechanical Ventilation Support [Up to 28 Days]

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

19. Number of Participants Who Required Invasive Mechanical Ventilation Support [Up to 28 Days]

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

20. Time to End of Invasive Mechanical Ventilation Support [Up to 28 Days]

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

21. Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score [Up to 28 Days]

    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.

22. Number of Participants Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube [Up to 28 Days]

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

23. Time to Clinical Stability [Up to 28 Days]

    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.

24. Number of Participants in Each Ordinal Scale Category [Day 5/6 (Day of last study treatment)]

    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.

25. Number of Participants With All-Cause Mortality [Up to 28 Days]

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

26. RSV RNA Viral Load Over Time [Days 2, 3, 4, 5, 6, 7, 10, 14, and 28]

    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.

27. Peak Viral Load [Up to 28 Days]

    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.

28. Time to Peak Viral Load [Up to 28 Days]

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

29. Rate of Decline of Viral Load [Up to 28 Days]

    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.

30. Time to RSV RNA Viral Load Being Undetectable [Up to 28 Days]

    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.

31. Number of Participants With Undetectable Viral Load [Up to 28 Days]

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

32. RSV RNA Viral Load AUC up to Day 14 [Up to Day 14]

    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.

33. RSV RNA Viral Load AUC in Participants Assigned to a Longer Dosing Duration [Up to 1 Day after the last dose of study drug]

    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.

34. Number of Participants With Postbaseline Changes in the RSV Polymerase L Gene and Other Regions of the RSV Genome Compared With Baseline Sequences [Baseline up to 28 Days]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hospitalized (or in emergency room prior to hospitalization) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization

• Diagnosed with respiratory syncytial virus (RSV) infection based on polymerase chain reaction (PCR)-based assay with or without co infection with another respiratory pathogen (eg, influenza, human metapneumovirus, or bacteria)

• With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population and/or the RSV infection. This determination must be recorded in the participant's source documents and initialed by the investigator

• A woman must have a negative urine beta human chorionic gonadotropin at screening

• A woman must agree not to donate eggs (ova, oocytes) during the study and for at least 44 days after receiving the last dose of study drug

• Contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies A woman must be of non-childbearing potential defined as either: a) Postmenopausal: a postmenopausal state is defined as more than (>) 45 years and no menses for 12 consecutive months without an alternative medical cause, OR Permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy. b) Of childbearing potential and, if heterosexually active, also included: practicing a highly effective method of contraception (failure rate of less than (<) 1percent (%) per year when used consistently and correctly)

• Participants must have a body weight of at least 50.0 kilogram, at screening

Exclusion Criteria:

• Participants who are not expected to survive for more than 48 hours

• Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization

• Participants who are considered by the investigator to be immuno-compromised within the past 12 months, whether due to underlying medical condition (example, malignancy or genetic disorder) or medical therapy (example, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant)

• Participants with a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis

• Participants undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR, determined by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) of (<) 60 milliliters per minute (mL/min) per 1.73 meter square (m^2)

• Participants with 1 or more of the following laboratory abnormalities at screening as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table: Hemoglobin <9.5 gram per deciliter (g/dL), Platelet count <75,000 per millimeter cube (/mm^{³), White blood cell count <1,000/mm}³, Absolute neutrophil count <1,000/mm^³

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fresno	California	United States
2		Orange	California	United States
3		Stanford	California	United States
4		Eustis	Florida	United States
5		Atlanta	Georgia	United States
6		Chicago	Illinois	United States
7		Saint Louis	Missouri	United States
8		Butte	Montana	United States
9		Rochester	New York	United States
10		Syracuse	New York	United States
11		Bahia Blanca		Argentina
12		Barrio Parque Velez Sarfield		Argentina
13		Buenos Aires		Argentina
14		Ciudad de Buenos Aires		Argentina
15		Ciudad De La Plata		Argentina
16		Cordoba		Argentina
17		Córdoba		Argentina
18		La Plata		Argentina
19		Rosario		Argentina
20		Cairns		Australia
21		Geelong		Australia
22		Melbourne		Australia
23		South Brisbane		Australia
24		Sydney		Australia
25		Brugge		Belgium
26		Lier		Belgium
27		Belo Horizonte		Brazil
28		Passo Fundo		Brazil
29		Porto Alegre		Brazil
30		Ribeirao Preto		Brazil
31		Sao Paulo		Brazil
32		Kozloduy		Bulgaria
33		Petrich		Bulgaria
34		Ruse		Bulgaria
35		Sofia		Bulgaria
36		Veliko Tarnovo		Bulgaria
37		Hamilton	Ontario	Canada
38		Toronto	Ontario	Canada
39		Colombes		France
40		Dijon		France
41		La Tronche		France
42		Limoges		France
43		Lyon		France
44		Morlaix		France
45		Nantes		France
46		Paris		France
47		Poitiers		France
48		Suresnes		France
49		Tours		France
50		Marburg		Germany
51		Witten		Germany
52		Fukuoka		Japan
53		Fukushima		Japan
54		Gifu		Japan
55		Gunma		Japan
56		Hamamatue		Japan
57		Isahaya		Japan
58		Izumo		Japan
59		Kitakyusyu		Japan
60		Kobe-city,		Japan
61		Nagasaki		Japan
62		Nagoya		Japan
63		Osaka		Japan
64		Ota		Japan
65		Sendai		Japan
66		Seto		Japan
67		Shiogama		Japan
68		Tanabe		Japan
69		Tokai-mura		Japan
70		Tokyo		Japan
71		Tsu		Japan
72		Uruma		Japan
73		Bucheon		Korea, Republic of
74		Daegu		Korea, Republic of
75		Gwangju		Korea, Republic of
76		Incheon		Korea, Republic of
77		Seongnam		Korea, Republic of
78		Seoul		Korea, Republic of
79		Johor Bharu		Malaysia
80		Kuala Lumpur		Malaysia
81		Kuala		Malaysia
82		Kuching		Malaysia
83		Melaka		Malaysia
84		Miri		Malaysia
85		Taiping		Malaysia
86		Cuernavaca		Mexico
87		Guadalajara		Mexico
88		Mexico		Mexico
89		Monterrey		Mexico
90		Leiden		Netherlands
91		Utrecht		Netherlands
92		Białystok		Poland
93		Chęciny		Poland
94		Mrozy		Poland
95		Proszowice		Poland
96		Elche		Spain
97		Granada		Spain
98		Madrid		Spain
99		Santiago de Compostela		Spain
100		Vigo		Spain
101		Göteborg		Sweden
102		Malmö		Sweden
103		Umeå		Sweden
104		Uppsala		Sweden
105		Kaohsiung		Taiwan
106		New Taipei		Taiwan
107		Tainan		Taiwan
108		Taipei		Taiwan
109		London		United Kingdom
110		Southampton		United Kingdom

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

• Study Protocol - Mar 20, 2018
• Statistical Analysis Plan - Oct 19, 2016

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT02935673
• Other Study ID Numbers: CR108217; 2016-001653-40; 64041575RSV2003
• First Posted: Oct 17, 2016
• Last Update Posted: Dec 24, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Virus Diseases

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Period Title: Overall Study
STARTED	16	27	6
COMPLETED	15	24	6
NOT COMPLETED	1	3	0

Baseline Characteristics

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine	Total
Arm/Group Description	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).	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).	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 of all reporting groups
Overall Participants	16	27	6	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.5 (17.94)	66.3 (17.75)	68.7 (18.46)	66.3 (17.54)
Sex: Female, Male (Count of Participants)
Female	5 31.3%	9 33.3%	5 83.3%	19 38.8%
Male	11 68.8%	18 66.7%	1 16.7%	30 61.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 12.5%	2 7.4%	0 0%	4 8.2%
Not Hispanic or Latino	14 87.5%	25 92.6%	6 100%	45 91.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	4 25%	11 40.7%	3 50%	18 36.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	12 75%	14 51.9%	3 50%	29 59.2%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 7.4%	0 0%	2 4.1%
Region of Enrollment (Count of Participants)
ARGENTINA	2 12.5%	0 0%	0 0%	2 4.1%
AUSTRALIA	3 18.8%	3 11.1%	1 16.7%	7 14.3%
FRANCE	1 6.3%	6 22.2%	0 0%	7 14.3%
JAPAN	3 18.8%	3 11.1%	3 50%	9 18.4%
MALAYSIA	0 0%	2 7.4%	0 0%	2 4.1%
POLAND	0 0%	2 7.4%	0 0%	2 4.1%
SOUTH KOREA	1 6.3%	3 11.1%	0 0%	4 8.2%
SPAIN	1 6.3%	2 7.4%	0 0%	3 6.1%
SWEDEN	3 18.8%	2 7.4%	2 33.3%	7 14.3%
TAIWAN	0 0%	3 11.1%	0 0%	3 6.1%
UNITED KINGDOM	1 6.3%	0 0%	0 0%	1 2%
UNITED STATES	1 6.3%	1 3.7%	0 0%	2 4.1%

Outcome Measures

1. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1
Description	Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).
Measure Participants	26	4
Mean (Standard Deviation) [nanogram per milliliter (ng/mL)]	1845 (545.2)	2801 (1509)

2. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5
Description	Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).
Measure Participants	22	2
Mean (Standard Deviation) [ng/mL]	745.4 (164.2)	1145 (440.8)

3. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).
Measure Participants	26	4
Mean (Standard Deviation) [nanogram*hour per milliliter (ng*h/mL)]	9936 (2090)	17120 (4330)

4. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5
Description	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.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).
Measure Participants	22	2
Mean (Standard Deviation) [ng*h/mL]	7557 (1525)	13300 (4603)

5. Primary Outcome

Title	Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1
Description	Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).
Measure Participants	26	4
Mean (Standard Deviation) [ng/mL]	93.7 (44.16)	184.4 (70.66)

6. Primary Outcome

Title	Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5
Description	Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).
Measure Participants	22	2
Mean (Standard Deviation) [ng/mL]	148.3 (60.41)	281.3 (156.6)

7. Primary Outcome

Title	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])
Description	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.
Time Frame	Day 1 (Baseline) to 7

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Day 2	-0.3	-1.4	-2.5
Day 3	-1.4	-1.9	-1.9
Day 4	-2.1	-2.2	-1.8
Day 5	-2.5	-2.5	-1.3
Day 6	-2.5	-2.7	-3.1
Day 7	-2.8	-2.8	-3.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	750 mg LD / 250 mg MD Lumicitabine, 1000 mg LD / 500 mg MD Lumicitabine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	AUC(1-7) difference vs (pooled) placebo
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.89 to 0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	750 mg LD / 250 mg MD Lumicitabine, 1000 mg LD / 500 mg MD Lumicitabine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	AUC(1-7) difference vs (pooled) placebo
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -1.33 to 0.62
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.

8. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	16	27	6
Count of Participants [Participants]	7 43.8%	22 81.5%	5 83.3%

9. Secondary Outcome

Title	Number of Participants With Vital Sign Abnormalities
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	16	27	6
Systolic BP (Abnormally low)	1 6.3%	0 0%	0 0%
Systolic BP (Grade 1 or mild)	2 12.5%	6 22.2%	2 33.3%
Systolic BP (Grade 2 or moderate)	5 31.3%	4 14.8%	0 0%
Systolic BP (Grade 3 or severe)	1 6.3%	1 3.7%	1 16.7%
Diastolic BP (Abnormally low)	2 12.5%	1 3.7%	1 16.7%
Diastolic BP (Grade 1 or mild)	5 31.3%	8 29.6%	1 16.7%
Diastolic BP (Grade 2 or moderate)	3 18.8%	1 3.7%	0 0%
Diastolic BP (Grade 3 or severe)	0 0%	1 3.7%	0 0%
Pulse Rate (Abnormally high)	2 12.5%	1 3.7%	0 0%
Respiratory Rate (Grade 1 or mild)	2 12.5%	0 0%	1 16.7%
Respiratory Rate (Grade 2 or moderate)	4 25%	6 22.2%	1 16.7%
Respiratory Rate (Grade 3 or severe)	3 18.8%	2 7.4%	0 0%
Temperature (Abnormally high)	4 25%	2 7.4%	0 0%
Oxygen Saturation (Abnormally low)	7 43.8%	9 33.3%	2 33.3%

10. Secondary Outcome

Title	Number of Participants With QT Interval Abnormalities
Description	Number of participants with QT interval abnormalities (prolonged) were reported.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	24	5
Count of Participants [Participants]	0 0%	1 3.7%	0 0%

11. Secondary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities
Description	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
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	16	27	6
Bicarbonate : Low	0 0%	2 7.4%	0 0%
Bicarbonate: High	3 18.8%	5 18.5%	0 0%
Chloride : Low	0 0%	3 11.1%	0 0%
Chloride : High	0 0%	2 7.4%	0 0%
Creatine Kinase : Low	4 25%	2 7.4%	3 50%
Creatine Kinase ; High	0 0%	0 0%	1 16.7%
Direct Bilirubin : High	0 0%	1 3.7%	0 0%
Indirect Bilirubin : Low	1 6.3%	0 0%	2 33.3%
Basophils : High	0 0%	0 0%	1 16.7%
Eosinophils : High	3 18.8%	1 3.7%	1 16.7%
Erythrocytes MCHC : Low	1 6.3%	1 3.7%	0 0%
Erythrocytes MCH : Low	1 6.3%	0 0%	0 0%
Erythrocytes MCH : High	0 0%	3 11.1%	1 16.7%
Erythrocytes : Low	5 31.3%	3 11.1%	1 16.7%
Ery. Distribution Width : Low	0 0%	1 3.7%	0 0%
Ery. Distribution Width : High	2 12.5%	5 18.5%	3 50%
Hematocrit : Low	4 25%	5 18.5%	0 0%
Hematocrit : High	1 6.3%	0 0%	0 0%
Lymphocytes : Low	0 0%	4 14.8%	0 0%
Lymphocytes : High	4 25%	3 11.1%	2 33.3%
Monocyte : Low	0 0%	2 7.4%	1 16.7%
Monocyte : High	5 31.3%	5 18.5%	3 50%
Reticulocytes : Low	0 0%	1 3.7%	2 33.3%
Reticulocytes : High	4 25%	2 7.4%	4 66.7%
Reticulocytes/Erythrocytes : Low	1 6.3%	0 0%	1 16.7%
Reticulocytes/Erythrocytes : High	4 25%	9 33.3%	3 50%

12. Secondary Outcome

Title	Time of Hospital Stay From Study Treatment Initiation to Discharge
Description	It is the time from treatment initiation to hospital discharge in hours.
Time Frame	From study treatment initiation to discharge (Up to 28 Days)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Mean (Standard Deviation) [Hours]	183.91 (217.020)	146.72 (94.910)	405.24 (294.771)

13. Secondary Outcome

Title	Time of Hospital Stay From Admission to Discharge
Description	It is the time from hospital admission to hospital discharge in hours.
Time Frame	From admission to discharge (Up to 28 Days)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	10	17	3
Mean (Standard Deviation) [Hours]	192.40 (199.363)	181.97 (107.938)	297.53 (348.729)

14. Secondary Outcome

Title	Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge
Description	It is the time from study treatment initiation to readiness for discharge in hours, with readiness for discharge defined by the investigator.
Time Frame	From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Mean (Standard Deviation) [Hours]	111.05 (78.237)	144.17 (96.019)	197.60 (256.702)

15. Secondary Outcome

Title	Time of Hospital Stay From Admission to Readiness for Discharge
Description	It is the time from hospital admission to readiness for discharge in hours, with readiness for discharge defined by the investigator.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	10	17	3
Mean (Standard Deviation) [Hours]	133.41 (83.057)	178.82 (108.522)	297.13 (349.159)

16. Secondary Outcome

Title	Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment
Description	Number of participants who required to be admitted to the ICU since initiation of treatment were reported.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Count of Participants [Participants]	0 0%	0 0%	0 0%

17. Secondary Outcome

Title	Duration of Intensive Care Unit Stay
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

18. Secondary Outcome

Title	Number of Participants Who Required Supplemental Oxygen
Description	Number of participants who required supplemental oxygen were reported.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Count of Participants [Participants]	14 87.5%	18 66.7%	4 66.7%

19. Secondary Outcome

Title	Time to End of Oxygen Supplementation
Description	It is the time from first dose of study drug to the last end date and time of any oxygen supplementation in hours.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	14	18	4
Mean (Standard Deviation) [Hours]	83.92 (168.125)	139.38 (237.584)	132.40 (288.568)

20. Secondary Outcome

Title	Time (Number of Hours) Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=) 93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to the Onset of Respiratory Symptoms
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

21. Secondary Outcome

Title	Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Mean (Standard Deviation) [Hours]	64.72 (180.542)	47.75 (153.293)	196.96 (290.694)

22. Secondary Outcome

Title	Time to Return to Pre-RSV Disease Level for Oxygen Saturation
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Mean (Standard Deviation) [Hours]	55.55 (85.915)	33.85 (57.703)	47.56 (106.347)

23. Secondary Outcome

Title	Time to Return to Pre-RSV Disease Level for Body Temperature
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

24. Secondary Outcome

Title	Number of Participants Who Required Noninvasive Mechanical Ventilation Support
Description	Number of participants who required noninvasive mechanical ventilation support (that is supplemental oxygen [excluding mechanical ventilation]) were reported.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Count of Participants [Participants]	14 87.5%	18 66.7%	4 66.7%

25. Secondary Outcome

Title	Time to End of Noninvasive Mechanical Ventilation Support
Description	It is the time from first dose of study drug to the last end date and time of noninvasive mechanical ventilation support in hours.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	14	18	4
Mean (Standard Deviation) [Hours]	83.92 (168.125)	139.38 (237.584)	132.40 (288.568)

26. Secondary Outcome

Title	Number of Participants Who Required Invasive Mechanical Ventilation Support
Description	Number of participants who required invasive mechanical ventilation support were reported.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Count of Participants [Participants]	0 0%	0 0%	0 0%

27. Secondary Outcome

Title	Time to End of Invasive Mechanical Ventilation Support
Description	It is the time from first dose of study drug to the last end date and time of invasive mechanical ventilation support in hours.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

28. Secondary Outcome

Title	Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Mean (Standard Deviation) [Days]	3.60 (7.434)	4.48 (6.961)	6.00 (11.203)

29. Secondary Outcome

Title	Number of Participants Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube
Description	Number of participants who required hydration or feeding by IV catheter or nasogastric tube were reported.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Count of Participants [Participants]	3 18.8%	5 18.5%	1 16.7%

30. Secondary Outcome

Title	Time to Clinical Stability
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Mean (Standard Deviation) [Hours]	151.21 (266.460)	171.74 (261.384)	207.00 (282.955)

31. Secondary Outcome

Title	Number of Participants in Each Ordinal Scale Category
Description	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.
Time Frame	Day 5/6 (Day of last study treatment)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Category 1	0 0%	0 0%	0 0%
Category 2	0 0%	1 3.7%	0 0%
Category 3	2 12.5%	5 18.5%	1 16.7%
Category 4	6 37.5%	8 29.6%	1 16.7%
Category 5	5 31.3%	2 7.4%	1 16.7%
Category 6	2 12.5%	5 18.5%	2 33.3%

32. Secondary Outcome

Title	Number of Participants With All-Cause Mortality
Description	All-cause mortality included all deaths of participants due to any cause.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	16	27	6
Count of Participants [Participants]	0 0%	0 0%	0 0%

33. Secondary Outcome

Title	RSV RNA Viral Load Over Time
Description	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.
Time Frame	Days 2, 3, 4, 5, 6, 7, 10, 14, and 28

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Day 2	5.9257 (1.95951)	4.7208 (1.60154)	3.4242 (1.10867)
Day 3	4.8255 (1.84651)	4.3515 (1.97633)	4.3129 (0.99078)
Day 4	4.0608 (1.57493)	3.9345 (1.64600)	4.0729 (1.15419)
Day 5	3.6463 (1.44056)	3.6206 (1.71515)	4.5344 (0.97473)
Day 6	3.6996 (1.98383)	3.4313 (1.57700)	3.2163 (1.30083)
Day 7	3.4044 (1.75773)	3.2306 (1.58432)	2.6147 (0.89779)
Day 10	2.5966 (1.04644)	2.7516 (1.72825)	2.5792 (1.00954)
Day 14	2.3605 (1.00220)	2.3010 (1.03732)	2.1512 (0.50236)
Day 28	1.9179 (0.06682)	1.9714 (0.22559)	1.9000 (0.00000)

34. Secondary Outcome

Title	Peak Viral Load
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

35. Secondary Outcome

Title	Time to Peak Viral Load
Description	Time to peak viral load is the time from initiation of study treatment until the first time point with the peak viral load.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

36. Secondary Outcome

Title	Rate of Decline of Viral Load
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

37. Secondary Outcome

Title	Time to RSV RNA Viral Load Being Undetectable
Description	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.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

38. Secondary Outcome

Title	Number of Participants With Undetectable Viral Load
Description	Number of participants with undetectable viral load up to 28 days were reported.
Time Frame	Up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	15	21	5
Count of Participants [Participants]	14 87.5%	19 70.4%	5 83.3%

39. Secondary Outcome

Title	RSV RNA Viral Load AUC up to Day 14
Description	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.
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

40. Secondary Outcome

Title	RSV RNA Viral Load AUC in Participants Assigned to a Longer Dosing Duration
Description	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.
Time Frame	Up to 1 Day after the last dose of study drug

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	0	0	0

41. Secondary Outcome

Title	Number of Participants With Postbaseline Changes in the RSV Polymerase L Gene and Other Regions of the RSV Genome Compared With Baseline Sequences
Description	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.
Time Frame	Baseline up to 28 Days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	750 mg LD / 250 mg MD Lumicitabine	1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).	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).	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).
Measure Participants	10	12	4
Count of Participants [Participants]	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Up to 28 Days
Arm/Group Title	Placebo		750 mg LD / 250 mg MD Lumicitabine		1000 mg LD / 500 mg MD Lumicitabine
Arm/Group Description	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).		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).		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).
All Cause Mortality
	Placebo		750 mg LD / 250 mg MD Lumicitabine		1000 mg LD / 500 mg MD Lumicitabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/27 (0%)		0/6 (0%)
Serious Adverse Events
	Placebo		750 mg LD / 250 mg MD Lumicitabine		1000 mg LD / 500 mg MD Lumicitabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/16 (12.5%)		4/27 (14.8%)		1/6 (16.7%)
Blood and lymphatic system disorders
Pancytopenia	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Cardiac disorders
Cardiac Failure	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Gastrointestinal disorders
Intestinal Obstruction	0/16 (0%)		1/27 (3.7%)		0/6 (0%)
Infections and infestations
Influenza	0/16 (0%)		1/27 (3.7%)		0/6 (0%)
Pneumonia	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Injury, poisoning and procedural complications
Thermal Burn	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease	0/16 (0%)		1/27 (3.7%)		0/6 (0%)
Skin and subcutaneous tissue disorders
Rash	0/16 (0%)		1/27 (3.7%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		750 mg LD / 250 mg MD Lumicitabine		1000 mg LD / 500 mg MD Lumicitabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/16 (37.5%)		17/27 (63%)		5/6 (83.3%)
Blood and lymphatic system disorders
Eosinophilia	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Febrile Neutropenia	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Gastrointestinal disorders
Abdominal Pain Upper	0/16 (0%)		2/27 (7.4%)		1/6 (16.7%)
Diarrhoea	1/16 (6.3%)		1/27 (3.7%)		0/6 (0%)
Gastritis	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
General disorders
Asthenia	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Chest Pain	2/16 (12.5%)		2/27 (7.4%)		0/6 (0%)
Oedema Peripheral	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Pyrexia	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Hepatobiliary disorders
Hepatic Function Abnormal	0/16 (0%)		2/27 (7.4%)		0/6 (0%)
Infections and infestations
Acarodermatitis	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Respiratory Tract Infection Bacterial	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Urinary Tract Infection	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Injury, poisoning and procedural complications
Overdose	1/16 (6.3%)		3/27 (11.1%)		0/6 (0%)
Investigations
Alanine Aminotransferase Increased	1/16 (6.3%)		2/27 (7.4%)		1/6 (16.7%)
Aspartate Aminotransferase Increased	0/16 (0%)		1/27 (3.7%)		1/6 (16.7%)
Blood Creatine Phosphokinase Increased	0/16 (0%)		2/27 (7.4%)		0/6 (0%)
Blood Fibrinogen Increased	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
C-Reactive Protein Increased	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Eosinophil Count Increased	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Gamma-Glutamyltransferase Increased	1/16 (6.3%)		1/27 (3.7%)		0/6 (0%)
Hepatic Enzyme Increased	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Occult Blood Positive	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Metabolism and nutrition disorders
Hyperglycaemia	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	0/16 (0%)		2/27 (7.4%)		0/6 (0%)
Nervous system disorders
Headache	0/16 (0%)		2/27 (7.4%)		0/6 (0%)
Somnolence	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Psychiatric disorders
Insomnia	2/16 (12.5%)		0/27 (0%)		0/6 (0%)
Renal and urinary disorders
Nephrolithiasis	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Renal Impairment	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/16 (0%)		2/27 (7.4%)		0/6 (0%)
Chronic Obstructive Pulmonary Disease	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Haemoptysis	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Skin and subcutaneous tissue disorders
Acne	1/16 (6.3%)		0/27 (0%)		0/6 (0%)
Alopecia	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Erythema	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Haemorrhage Subcutaneous	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Hyperhidrosis	0/16 (0%)		2/27 (7.4%)		0/6 (0%)
Rash	1/16 (6.3%)		3/27 (11.1%)		1/6 (16.7%)
Vascular disorders
Deep Vein Thrombosis	0/16 (0%)		0/27 (0%)		1/6 (16.7%)
Hypertension	1/16 (6.3%)		1/27 (3.7%)		0/6 (0%)

Limitations/Caveats

As the study was stopped prematurely the planned final analyses were adapted. Due to small number of participants in Part 2, it was decided to pool the data from the 3 parts of the study to perform an evaluation of selected planned analyses only.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.