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MK-0476, montelukast

Phase 2

Bronchiolitis | Small molecule | Other |Organon & Co.|Last Updated: Aug 14, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00394069PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)PHASE2 COMPLETED 14 — — Jul 1, 2003Dec 1, 2003Aug 14, 2024 - —
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months.
14 days
Secondary Endpoints
To estimate the single-dose population pharmacokinetics, maximum plasma concentration, time to maximum plasma concentration, and apparent half-life of montelukast 4-mg oral granules in children aged 3 to 6 months.
24 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Montelukast sodiumEXPERIMENTALParticipants receive montelukast sodium for 14 days.
Interventions
NameTypeDescription
MK-0476, montelukast sodiumDRUGDuration of Treatment: 14 Days
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Eligibility Criteria
Age Range3 Months — 6 Months
SexALL
Healthy VolunteersNo

Inclusion Criteria : * Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms Exclusion Criteria : * A history of any significant illness that will pose additional risk to the patient

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