Trial · NCT06102174
A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
NCT06102174, Phase 1, Terminated, Pfizer; results first posted 2025-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV. Trials, record NCT06102174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06102174
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
- NCT number
- NCT06102174
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Placebo, Active
- First posted
- 2023-10-26
- Last updated
- 2025-12-30
- Results first posted
- 2025-12-30
- Limitations and caveats
- Sponsor decided to maintain company confidentiality, hence dose strengths, dose frequency, and PK sampling time points have not been disclosed in the record.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. All AEs were included for evaluation. |
| Primary | Number of Participants Who Discontinued From Study Due to TEAEs | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. |
| Primary | Number of Participants Who Discontinued From Study Due to Serious TEAEs | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. A serious AE (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation if existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; other important event or situation as pre-specified in protocol. |
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, mean cell volume, mean cell hemoglobin \& concentration); chemistry: urea and creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyl transferase (GGT), calcium, sodium, potassium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase, albumin, total protein, cystatin C; urinalysis: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, albumin, creatinine (urine), urine albumin to creatinine ratio. Clinically significant laboratory abnormalities findings were based on investigator discretion. |
| Primary | Number of Participants With Clinically Significant Vital Signs | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | Vital signs included systolic and diastolic blood pressure, pulse rate/heart rate, temperature, respiratory rate, and oxygen saturation. Clinically significance vital signs findings were based on investigator discretion. |
| Secondary | Plasma Concentrations Versus Time Summary of Sisunatovir | Day 3: Pre-dose, T1 and T2 hours post-dose; Day 5: Pre-dose; where T1 is the first analysis time point post-dose while T2 is the second analysis time point post-dose |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued From Study Due to TEAEs | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued From Study Due to Serious TEAEs | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Vital Signs | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentrations Versus Time Summary of Sisunatovir | Day 3: Pre-dose, T1 and T2 hours post-dose; Day 5: Pre-dose; where T1 is the first analysis time point post-dose while T2 is the second analysis time point post-dose | Pharmacokinetic (PK) concentration set: all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 concentration value can be reported. Number Analyzed: participants evaluable for specified timepoints, if its value is 0 it means data was missing, PK concentration was not collected at respective timepoint and arm. Data was analyzed and reported only for those arms where participants took sisunatovir, not for placebo arms. | Nanogram per milliliter | MEDIAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Cohort 1A: Sisunatovir | 0 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Cohort 1A: Placebo | 1 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Cohort 1B: Sisunatovir | 1 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Cohort 1B: Placebo | 1 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Cohort 1C: Sisunatovir | 3 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Cohort 1C: Placebo | 1 | Participants | ||
| Number of Participants Who Discontinued From Study Due to TEAEs | Cohort 1A: Sisunatovir | 0 | Participants | ||
| Number of Participants Who Discontinued From Study Due to TEAEs | Cohort 1A: Placebo | 0 | Participants | ||
| Number of Participants Who Discontinued From Study Due to TEAEs | Cohort 1B: Sisunatovir | 0 | Participants | ||
| Number of Participants Who Discontinued From Study Due to TEAEs | Cohort 1B: Placebo | 0 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1A: Sisunatovir | 1 | |
| Overall Study | STARTED | Cohort 1A: Placebo | 1 | |
| Overall Study | STARTED | Cohort 1B: Sisunatovir | 2 | |
| Overall Study | STARTED | Cohort 1B: Placebo | 1 | |
| Overall Study | STARTED | Cohort 1C: Sisunatovir | 3 | |
| Overall Study | STARTED | Cohort 1C: Placebo | 2 | |
| Overall Study | COMPLETED | Cohort 1A: Sisunatovir | 1 | |
| Overall Study | COMPLETED | Cohort 1A: Placebo | 1 | |
| Overall Study | COMPLETED | Cohort 1B: Sisunatovir | 2 | |
| Overall Study | COMPLETED | Cohort 1B: Placebo | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events72
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 | Constipation | Gastrointestinal disorders | Cohort 1A: Sisunatovir | 0 | 1 | |
| other | Constipation | Gastrointestinal disorders | Cohort 1A: Placebo | 1 | 1 | |
| other | Constipation | Gastrointestinal disorders | Cohort 1B: Sisunatovir | 1 | 2 | |
| other | Constipation | Gastrointestinal disorders | Cohort 1B: Placebo | 0 | 1 | |
| other | Constipation | Gastrointestinal disorders | Cohort 1C: Sisunatovir | 0 | 3 | |
| other | Constipation | Gastrointestinal disorders | Cohort 1C: Placebo | 0 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1A: Sisunatovir | 0 | 1 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1A: Placebo | 0 | 1 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1B: Sisunatovir | 1 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1B: Placebo | 0 | 1 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1A: Sisunatovir | 0 | 1 |
| Total, all-cause mortality | Cohort 1A: Placebo | 0 | 1 |
| Total, all-cause mortality | Cohort 1B: Sisunatovir | 0 | 2 |
| Total, all-cause mortality | Cohort 1B: Placebo | 0 | 1 |
| Total, all-cause mortality | Cohort 1C: Sisunatovir | 0 | 3 |
| Total, all-cause mortality | Cohort 1C: Placebo | 0 | 2 |
| Total, other adverse events | Cohort 1A: Sisunatovir | 0 | 1 |
| Total, other adverse events | Cohort 1A: Placebo | 1 | 1 |
| Total, other adverse events | Cohort 1B: Sisunatovir | 1 | 2 |
| Total, other adverse events | Cohort 1B: Placebo | 1 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41673909 | 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/NCT06102174
GET https://conductscience.org/api/trials/v1/NCT06102174/results?page=2