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Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms

NCT03653364 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-05-17

Study results available
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Summary

This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to \<1 year with influenza like symptoms

Conditions

Interventions

DRUG

Baloxavir Marboxil

Participants will receive single oral dose of baloxavir marboxil on Day 1 based on body weight and age. Participants aged ≥ 3 months to \<12 months old received baloxavir marboxil, 2 milligrams per kilograms (mg/kg). Participants from birth to \< 4 weeks old and ≥ 4 weeks to \< 3 months old received baloxavir marboxil, 1 mg/kg.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-23
Primary Completion
2023-04-03
Completion
2023-04-03
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Costa Rica
  • Finland
  • Israel
  • Poland
  • Russia
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653364 on ClinicalTrials.gov