Trial · NCT02935673
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
NCT02935673, Phase 2, Terminated, Janssen Research & Development, LLC; results first posted 2019-12-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02935673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02935673
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus
- NCT number
- NCT02935673
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Respiratory Syncytial Viruses
- Interventions
- lumicitabine, Placebo
- First posted
- 2016-10-17
- Last updated
- 2019-12-24
- Other registries' IDs
- eudract:2016-001653-40
- Results first posted
- 2019-12-24
- Limitations and 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.
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | Number of Participants With QT Interval Abnormalities | Up to 28 Days | Number of participants with QT interval abnormalities (prolonged) were reported. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1 | Day 1 | 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. | nanogram per milliliter (ng/mL) | MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5 | Day 5 | 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. | ng/mL | MEAN |
| PRIMARY | 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 | 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. | nanogram*hour per milliliter (ng*h/mL) | MEAN |
| PRIMARY | 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 | 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. | ng*h/mL | MEAN |
| PRIMARY | Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1 | Day 1 | 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. | ng/mL | MEAN |
| PRIMARY | Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5 | Day 5 | 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. | ng/mL | MEAN |
| PRIMARY | 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 | 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. | log10 copies/mL/day | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up to 28 Days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Sign Abnormalities | Up to 28 Days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With QT Interval Abnormalities | Up to 28 Days | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group255
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1 | 750 mg LD / 250 mg MD Lumicitabine | 1845 | Standard Deviation 545.2 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1 | 1000 mg LD / 500 mg MD Lumicitabine | 2801 | Standard Deviation 1509 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5 | 750 mg LD / 250 mg MD Lumicitabine | 745.4 | Standard Deviation 164.2 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5 | 1000 mg LD / 500 mg MD Lumicitabine | 1145 | Standard Deviation 440.8 | ng/mL | |
| Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1 | 750 mg LD / 250 mg MD Lumicitabine | 9936 | Standard Deviation 2090 | nanogram*hour per milliliter (ng*h/mL) | |
| Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1 | 1000 mg LD / 500 mg MD Lumicitabine | 17120 | Standard Deviation 4330 | nanogram*hour per milliliter (ng*h/mL) | |
| Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5 | 750 mg LD / 250 mg MD Lumicitabine | 7557 | Standard Deviation 1525 | ng*h/mL | |
| Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5 | 1000 mg LD / 500 mg MD Lumicitabine | 13300 | Standard Deviation 4603 | ng*h/mL | |
| Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1 | 750 mg LD / 250 mg MD Lumicitabine | 93.7 | Standard Deviation 44.16 | ng/mL | |
| Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1 | 1000 mg LD / 500 mg MD Lumicitabine | 184.4 | Standard Deviation 70.66 | ng/mL |
1 to 10 of 255Source ClinicalTrials.gov
See all 255 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | STARTED | 750 mg LD / 250 mg MD Lumicitabine | 27 | |
| Overall Study | STARTED | 1000 mg LD / 500 mg MD Lumicitabine | 6 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | COMPLETED | 750 mg LD / 250 mg MD Lumicitabine | 24 | |
| Overall Study | COMPLETED | 1000 mg LD / 500 mg MD Lumicitabine | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | 750 mg LD / 250 mg MD Lumicitabine | 3 | |
| Overall Study | NOT COMPLETED | 1000 mg LD / 500 mg MD Lumicitabine | 0 |
Source ClinicalTrials.gov
Adverse events147
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eosinophilia | Blood and lymphatic system disorders | Placebo | 0 | 16 | |
| other | Eosinophilia | Blood and lymphatic system disorders | 750 mg LD / 250 mg MD Lumicitabine | 0 | 27 | |
| other | Eosinophilia | Blood and lymphatic system disorders | 1000 mg LD / 500 mg MD Lumicitabine | 1 | 6 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Placebo | 0 | 16 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | 750 mg LD / 250 mg MD Lumicitabine | 0 | 27 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | 1000 mg LD / 500 mg MD Lumicitabine | 1 | 6 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Placebo | 0 | 16 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | 750 mg LD / 250 mg MD Lumicitabine | 2 | 27 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | 1000 mg LD / 500 mg MD Lumicitabine | 1 | 6 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 16 |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 16 |
| Total, all-cause mortality | 750 mg LD / 250 mg MD Lumicitabine | 0 | 27 |
| Total, all-cause mortality | 1000 mg LD / 500 mg MD Lumicitabine | 0 | 6 |
| Total, other adverse events | Placebo | 6 | 16 |
| Total, other adverse events | 750 mg LD / 250 mg MD Lumicitabine | 17 | 27 |
| Total, other adverse events | 1000 mg LD / 500 mg MD Lumicitabine | 5 | 6 |
| Total, serious adverse events | Placebo | 2 | 16 |
| Total, serious adverse events | 750 mg LD / 250 mg MD Lumicitabine | 4 | 27 |
| Total, serious adverse events | 1000 mg LD / 500 mg MD Lumicitabine | 1 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02935673
GET https://conductscience.org/api/trials/v1/NCT02935673/registered?page=2