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GLPG0634 once a day for 10 days

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Mar 28, 2013

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01665924Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy SubjectsPHASE1 COMPLETED 36 — — Jul 1, 2012Oct 1, 2012Mar 28, 20131 Belgium
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Study Endpoints
Primary Endpoints
The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634
From predose (before first study drug administration) up to 72 hours post last study drug administration

To characterize the amount of GLPG0634 in plasma over time - pharmacokinetics (PK) - after single and multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging

Secondary Endpoints
The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634
From predose (before first study drug administration) up to 24 hours post last study drug administration
Number of adverse events
From screening up to 10 days after the last study drug administration
Changes in vital signs as measured by heart rate, blood pressure and body temperature
From screening up to 10 days after the last study drug administration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
40-50 years oldEXPERIMENTALGLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old
65-74 years oldEXPERIMENTALGLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old
75 years and olderEXPERIMENTALGLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older
Interventions
NameTypeDescription
GLPG0634 100mg capsule once a day for 10 daysDRUG -
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female, age 40 years and older * 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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