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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

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06102174
Collaborator
(none)
108
Enrollment
2
Arms
9.1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
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)
Anticipated Study Start Date :
Nov 7, 2023
Anticipated Primary Completion Date :
Aug 9, 2024
Anticipated Study Completion Date :
Aug 9, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Oral or Nasogastric tube (NG)

Drug: Placebo
Placebo
Active Comparator: Sisunatovir

Oral or NG tube

Drug: Active
Sisunatovir
Other Names:
  • PF-07923568, RV521

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment Emergent Adverse Events (TEAEs) [Day 1 to Day 33]

    2. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuations [Day 1 to Day 33]

    3. Incidence of clinically significant abnormal laboratory values [Day 1 to Day 33]

    4. Incidence of clinically significant abnormal Electrocardiogram (ECG) parameters [Day 1 to Day 33]

    5. Incidence of clinically significant abnormal vital signs. [Day 1 to Day 33]

    Secondary Outcome Measures

    1. Plasma concentrations of sisunatovir at steady state (Day 3 or later). [Day 3 to Day 5]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 60 Months
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT06102174
    Other Study ID Numbers:
    • C5241009
    • 2023-504425-39-00
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pfizer
    Lower Respiratory Tract Infection
    Additional relevant MeSH terms:
    Infections
    Respiratory Tract Infections
    Respiratory Syncytial Virus Infections

    Study Results

    No Results Posted as of Oct 26, 2023