C5241009 - 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)

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504425-39-00

Acronym

C5241009

Enrollment

Registered

2023-11-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus (RSV) Infection

Brief summary

Incidence of TEAEs, Incidence of AEs and SAEs leading to discontinuations, Incidence of clinically significant abnormal laboratory values, ECG parameters and vital signs

Detailed description

Plasma concentrations of sisunatovir at steady state (Day 3 or later)

Interventions

DRUGPlacebo for sisunatovir 50 mg capsule

DRUGSisunatovir

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Incidence of TEAEs, Incidence of AEs and SAEs leading to discontinuations, Incidence of clinically significant abnormal laboratory values, ECG parameters and vital signs	—

Secondary

Measure	Time frame
Plasma concentrations of sisunatovir at steady state (Day 3 or later)	—

Countries

Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026