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Mebendazole - fasted state

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Jun 27, 2014

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment1
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02051738A Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy ParticipantsPHASE1 COMPLETED 1Feb 1, 2014Apr 1, 2014Jun 27, 20141 Belgium
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Study Endpoints
Primary Endpoints
Concentration of mebendazole in blood and urine under fed and fasted condition
Up to Day 5 of in each treatment period
Secondary Endpoints
Number of participants with adverse events
From screening up to 7 to 10 days after Day 5 of Treatment Period 2
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Sequence ABEXPERIMENTALA single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fasted condition (Treatment A) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fed condition (Treatment B).
Treatment Sequence BAEXPERIMENTALA single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fed condition (Treatment B) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fasted condition (Treatment A).
Interventions
NameTypeDescription
Mebendazole - fasted state (Treatment A)DRUGParticipants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition.
Mebendazole - fed state (Treatment B)DRUGParticipants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must have signed an informed consent document * Woman must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study * Woman must have a negative serum human chorionic gona...

Countries:Belgium
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