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GLPG1972 - A

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Jan 13, 2020

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04137341A Study in Healthy Volunteers to Compare Different Tablet Formulations of the Test Medicine, GLPG1972, Against the Current Tablet Formulation, and to Assess the Effect Food Has on One of the Test MedicinesPHASE1 COMPLETED 18 — — Oct 9, 2019Dec 13, 2019Jan 13, 20201 United Kingdom
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between tablet formulations
From Day 1 pre-dose up to Day 4

To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972

Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between tablet formulations
From Day 1 pre-dose up to Day 4

To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972

Maximum observed plasma concentration (Cmax) ratio between tablet formulations
From Day 1 pre-dose up to Day 4

To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972

Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between fed and fasted
From Day 1 pre-dose up to Day 4

To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972

Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between fed and fasted
From Day 1 pre-dose up to Day 4

To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972

Maximum observed plasma concentration (Cmax) ratio between fed and fasted
From Day 1 pre-dose up to Day 4

To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972

Secondary Endpoints
The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations
From Day 1 through study completion, an average of 2 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Tablet AEXPERIMENTALA single oral 300-mg dose of GLPG1972 in fasted state
Tablet BEXPERIMENTALA single oral 300-mg dose of GLPG1972 in fasted state
Tablet CEXPERIMENTALA single oral 300-mg dose of GLPG1972 in fasted state
Food effectEXPERIMENTALselected tablet B or C under fed conditions
Interventions
NameTypeDescription
GLPG1972 - ADRUGFilm-coated tablet, formulation A
GLPG1972 - BDRUGFilm-coated tablet, formulation B
GLPG1972 - CDRUGFilm-coated tablet, formulation C
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male between 18-55 years of age (extremes included), on the date of signing the informed consent form * A body mass index (BMI) between 18.0-30.0 kg/m2, inclusive * Judged to be in good health by the investigator based upon the results of medical history, physical examination,...

Countries:United Kingdom
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