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GLPG2737 single dose

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Jan 25, 2018

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03410979A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2737 in Healthy SubjectsPHASE1 COMPLETED 79Nov 25, 2016Aug 15, 2017Jan 25, 20181 Netherlands
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Study Endpoints
Primary Endpoints
Change versus placebo in the proportion of subjects with adverse events
Between screening and 14 days (SAD part) and 15 days (MAD part) after the last dose

To assess safety and tolerability of single and multiple ascending doses with GLPG2737 versus placebo in healthy subjects.

Secondary Endpoints
Maximum observed plasma concentration (Cmax) of GLPG2737
Between Day 1 predose and 5 days after the last dose
Time of occurrence of Cmax for GLPG2737 (tmax)
Between Day 1 predose and 5 days after the last dose
Area under the plasma concentration-time curve (AUC0-t) of GLPG2737
Between Day 1 predose and 5 days after the last dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
GLPG2737 single doseEXPERIMENTALSingle doses of GLPG2737 oral suspension at up to 5 dose levels in ascending order
Placebo single dosePLACEBO_COMPARATORSingle doses of Placebo oral suspension
GLP2737 multiple doseEXPERIMENTALMultiple doses of GLPG2737 oral suspension at up to 3 dose levels in ascending order
GLPG2737 multiple dosePLACEBO_COMPARATORMultiple doses of Placebo oral suspension
Interventions
NameTypeDescription
GLPG2737 single doseDRUGGLPG2737 oral suspension, single ascending doses
Placebo single doseDRUGPlacebo, oral suspension.
GLPG2737 multiple doseDRUGGLPG2737 oral suspension, multiple ascending doses, daily for 14 days.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male between 18-50 years of age, inclusive, on the date of signing the Informed Consent Form (ICF). 2. Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and clinical safety laboratory t...

Countries:Netherlands
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