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GLPG0555 solid dispersion

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Mar 24, 2011

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01278095Oral Bioavailability of GLPG0555 in Different Solid FormulationsPHASE1 COMPLETED 12Jan 1, 2011Mar 1, 2011Mar 24, 20111 Belgium
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Study Endpoints
Primary Endpoints
Bioavailability of solid formulation
72 hrs
Secondary Endpoints
Safety and tolerability of single doses of GLPG0555
up to 10 days postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
GLPG0555 solid dispersion, fastingEXPERIMENTAL50 mg as solid dispersion capsule, in fasting condition
GLPG0555 solid dispersion, fedEXPERIMENTAL50 mg as solid dispersion capsule, after breakfast
GLPG0555 nanosuspension, fedEXPERIMENTAL50 mg as nanosuspension, given after breakfast
Interventions
NameTypeDescription
GLPG0555 solid dispersionDRUGsolid dispersion capsules, 50 mg, single dose
GLPG0555 nanosuspensionDRUGNanosuspension, 50 mg, single dose
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy male * BMI between 18-30 kg/m², inclusive. Exclusion Criteria: * significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse

Countries:Belgium
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