AN INTERVENTIONAL, PHASE 1b, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, MULTI-CENTER, DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SISUNATOVIR IN PEDIATRIC PARTICIPANTS UP TO AGE 60 MONTHS WITH RESPIRATORY SYNCYTIAL VIRUS (RSV) LOWER RESPIRATORY TRACT INFECTION (LRTI)
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Pfizer
- Enrollment
- 10
- Locations
- 9
- Primary Endpoint
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Study Overview
Brief Summary
The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months. These children have Lower Respiratory Tract Infection (LRTI) caused by Respiratory Syncytial Virus (RSV). LRTI is the infection to the lower airways such as lungs.
This study will help inform the amount of sisunatovir to be used in future studies of sisunatovir in children.
This study is seeking for participants who:
- Are 1 day to less than or equal to 60 months of age
- weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms.
- Have been tested to have RSV by medical tests.
- show signs of LRTI.
All participants in the study will receive many amounts of sisunatovir or placebo. Placebo is a pill that does not have any medicine in it.
Up to 7 visits are required for the study. Some of these visits include checking participants health over the phone and/or a visit at home.
The study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 1 Day to 60 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1 day to ≤60 months of age and weight ≥2.5 kg to ≤23 kg
- •Positive RSV diagnostic test, antigen or molecular test
- •Evidence of Lower Respiratory Tract Infection (LRTI)
Exclusion Criteria
- •Premature infants (gestational age less than 35 weeks) AND <1 year of post-natal age
- •Neonates with intrauterine growth restriction
- •Expected to receive an antiviral for another viral infection within 10 days of screening
- •Suspected or confirmed clinically significant moderate or severe bacterial infection that may interfere with the evaluation of response to the study intervention
- •Known to have significant comorbidities that would limit the ability to administer the study intervention or evaluate the safety or clinical response to the study intervention
Arms & Interventions
Placebo
Oral or Nasogastric tube (NG)
Intervention: Placebo (Drug)
Sisunatovir
Oral or NG tube
Intervention: Active (Drug)
Outcomes
Primary Outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: 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.
Number of Participants Who Discontinued From Study Due to TEAEs
Time Frame: 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.
Number of Participants Who Discontinued From Study Due to Serious TEAEs
Time Frame: 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.
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: 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.
Number of Participants With Clinically Significant Vital Signs
Time Frame: 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 Outcomes
- 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)