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GLPG4716

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Nov 24, 2021

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
UNCONTROLLED
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05030857Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy SubjectsPHASE1 COMPLETED 19 — — Sep 8, 2021Nov 13, 2021Nov 24, 20211 Canada
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) of MDZ
From Day 1 pre-dose until Day 15

To determine the effect of GLPG4716 on the pharmacokinetics (PK) of MDZ

Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MDZ
From Day 1 pre-dose until Day 15

To determine the effect of GLPG4716 on the PK of MDZ

Secondary Endpoints
Cmax of GLPG4716
From Day 1 pre-dose until Day 15
Area under the plasma concentration-time curve over the dosing interval (AUCt) of GLPG4716
From Day 1 pre-dose until Day 15
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent (SAEs), and TEAEs leading to treatment discontinuations
From Day 1 through study completion, an average of one month
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
GLPG4716 and MidazolamEXPERIMENTAL -
Interventions
NameTypeDescription
GLPG4716DRUGFrom Day 3 to Day 14, participants will receive GLPG4716 tablets once daily in fasted state. On Day 8 GLPG4716 will be administered in fed state.
MidazolamDRUGOn Days 1, 3 and 13, participants will receive a single oral dose of MDZ as an oral solution in fasted state.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form. Female subjects should be of non-childbearing potential. * A body mass index between 18.0 and 30.0 kg/m2, inclusive. * Judged to be in good health by the invest...

Countries:Canada
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