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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
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Trial · NCT02935673

Results by group255

Each measurement the trial posted, group by group, in the words and numbers it posted.

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OutcomeGroupCategoryValueSpreadUnits
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1750 mg LD / 250 mg MD Lumicitabine1845Standard Deviation 545.2nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 11000 mg LD / 500 mg MD Lumicitabine2801Standard Deviation 1509nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5750 mg LD / 250 mg MD Lumicitabine745.4Standard Deviation 164.2ng/mL
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 51000 mg LD / 500 mg MD Lumicitabine1145Standard Deviation 440.8ng/mL
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1750 mg LD / 250 mg MD Lumicitabine9936Standard Deviation 2090nanogram*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 11000 mg LD / 500 mg MD Lumicitabine17120Standard Deviation 4330nanogram*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 5750 mg LD / 250 mg MD Lumicitabine7557Standard Deviation 1525ng*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 51000 mg LD / 500 mg MD Lumicitabine13300Standard Deviation 4603ng*h/mL
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1750 mg LD / 250 mg MD Lumicitabine93.7Standard Deviation 44.16ng/mL
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 11000 mg LD / 500 mg MD Lumicitabine184.4Standard Deviation 70.66ng/mL
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5750 mg LD / 250 mg MD Lumicitabine148.3Standard Deviation 60.41ng/mL
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 51000 mg LD / 500 mg MD Lumicitabine281.3Standard Deviation 156.6ng/mL
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])
PlaceboDay 2-0.395% Confidence Interval -0.9 to 0.3log10 copies/mL/day
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])
750 mg LD / 250 mg MD LumicitabineDay 2-1.495% Confidence Interval -2.0 to -0.9log10 copies/mL/day
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])
1000 mg LD / 500 mg MD LumicitabineDay 2-2.595% Confidence Interval -3.6 to -1.3log10 copies/mL/day
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])
PlaceboDay 3-1.495% Confidence Interval -2.1 to -0.7log10 copies/mL/day
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])
750 mg LD / 250 mg MD LumicitabineDay 3-1.995% Confidence Interval -2.5 to -1.2log10 copies/mL/day
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])
1000 mg LD / 500 mg MD LumicitabineDay 3-1.995% Confidence Interval -3.4 to -0.5log10 copies/mL/day
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])
PlaceboDay 4-2.195% Confidence Interval -2.8 to -1.4log10 copies/mL/day
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])
750 mg LD / 250 mg MD LumicitabineDay 4-2.295% Confidence Interval -2.8 to -1.6log10 copies/mL/day

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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.

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