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MK-0476, montelukast

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

MK-0476, montelukast · 1 trial · 1 indication

Phase 2 1
NCT00394069PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)Bronchiolitis
COMPLETED14 Analytics
PHASE2COMPLETED
PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
BronchiolitisUnlock trial analytics

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 to 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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Frequently asked questions about MK-0476, montelukast

What is MK-0476 used for?

MK-0476, also known as montelukast, is a small molecule being studied for respiratory conditions including seasonal allergic rhinitis, bronchiolitis, and bronchial asthma. It is currently in Phase 2 clinical development for these indications.

What does MK-0476 target?

MK-0476 is a small molecule being developed for respiratory conditions. Its specific molecular target has not been disclosed in available clinical trial information.

Who makes MK-0476?

MK-0476 is being developed by Organon & Co., a company traded on the New York Stock Exchange under the ticker symbol OGN.

What phase is MK-0476 in?

MK-0476 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the conditions under study.

What clinical trials is MK-0476 in?

MK-0476 has been studied in completed clinical trials, including NCT00092105 for asthma and perennial allergic rhinitis, NCT00092885 for seasonal allergic rhinitis with asthma, and NCT00394069 for bronchiolitis in young children.

Is MK-0476 the same as montelukast?

Yes, MK-0476 is also known as montelukast. Clinical trials reference montelukast sodium as the study drug, and the compound is being evaluated for respiratory indications.