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GLPG0187 prodrug

Phase 1

Healthy | Small molecule | Other |Lakefront Biotherapeutics|Last Updated: Apr 20, 2012

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

GLPG0187 prodrug · 1 trial · 1 indication

Phase 1 1
NCT01580644Bioavailability Study of Prodrug of GLPG0187 in Healthy VolunteersHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers
Healthy
NCT0158064412
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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 to 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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