Trial · NCT02593851
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection
NCT02593851, Phase 1, Terminated, Janssen Sciences Ireland UC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection. Trials, record NCT02593851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02593851
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection
- NCT number
- NCT02593851
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 45 participants, actual
- Lead sponsor
- Janssen Sciences Ireland UC
- Conditions
- Respiratory Syncytial Virus Infections, Virus Diseases
- Interventions
- JNJ-53718678, Placebo
- First posted
- 2015-11-02
- Last updated
- 2019-12-06
- Other registries' IDs
- eudract:2015-002003-28
Source ClinicalTrials.gov
Registered outcomes20
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-53718678 | Days 1, 2 and 3 | The Cmax is the maximum observed plasma concentration. |
| Primary | Trough Plasma Concentration (Ctrough) of JNJ-53718678 | Days 1, 2 and 3 | The Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen. |
| Primary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Days 1, 2 and 3 | The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. |
| Primary | Total Apparent Clearance (CL/F) of JNJ-53718678 | Days 1, 2 and 3 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Primary | Apparent Volume of Distribution (Vd/F) of JNJ-53718678 | Days 1, 2 and 3 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vd/F) is influenced by the fraction absorbed. |
| Primary | Number of Participants With Adverse Events | Up to Follow-up (Day 28) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Area Under the Viral Load-time Curve (VL AUC) | Up to Follow-up (Day 28) | VL will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs. The VL AUC (copies. hour/ml) will be calculated based on the trapezoidal method. |
| Secondary | Amount of Viral Load Over Time | Up to Follow-up (Day 28) | VL (copies/ml) at each assessment timepoint where a nasal sample is obtained. |
| Secondary | Number of viral particles at Peak Viral Load | Up to Follow-up (Day 28) | Peak viral load (copies/ml) is a measure of the maximum number of viral particles present in nasal swabs. |
| Secondary | Time To Peak Viral Load | Up to Follow-up (Day 28) | Time (hours) to peak viral load will be reported. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32201897 | DERIVED |
Source PubMed
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/NCT02593851
GET https://conductscience.org/api/trials/v1/NCT02593851/registered