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GLPG0187 prodrug

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Apr 20, 2012

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
CONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01580644Bioavailability Study of Prodrug of GLPG0187 in Healthy VolunteersPHASE1 COMPLETED 12Jan 1, 2012Mar 1, 2012Apr 20, 20121 Belgium
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Study Endpoints
Primary Endpoints
The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug

To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of either of 2 formulations of GLPG0187 prodrug in healthy subjects

Secondary Endpoints
The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food
The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food)
Number of adverse events
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Period 1: formulation 1 oral solutionEXPERIMENTAL -
Period 2: formulation 2 capsuleEXPERIMENTAL -
Period 3: Selected formulation + foodEXPERIMENTAL -
Period 4: Selected formulation at higher doseEXPERIMENTAL -
Interventions
NameTypeDescription
GLPG0187 prodrugDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male, age 18-50 years * BMI between 18-30 kg/m2 Exclusion Criteria: * Any condition that might interfere with the procedures or tests in this study * Drug or alcohol abuse * Smoking

Countries:Belgium
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