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GLPG3970 film-coated

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Jul 23, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04907149Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970PHASE1 COMPLETED 6 — — Jun 7, 2021Jul 12, 2021Jul 23, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
Absolute oral bioavailability (F [%]) of GLPG3970
From Day 1 pre-dose until Day 4 in Period 1
Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%).
From Day 1 pre-dose until Day 8 in Period 2
Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%).
From Day 1 pre-dose until Day 8 in Period 2
Secondary Endpoints
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
From Day 1 through study completion, an average of 1 month
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Absolute Bioavailability - Period 1EXPERIMENTALParticipants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of \[14C\]GLPG3970 on Day 1.
Mass Balance - Period 2EXPERIMENTALParticipants will receive \[14C\]GLPG397 under fasted conditions on Day 1.
Interventions
NameTypeDescription
GLPG3970 film-coated tabletDRUGParticipants will receive a single oral dose of GLPG3970.
[14C]GLPG3970 solution for infusionDRUGParticipants will receive an i.v. microtracer microdose.
[14]GLPG3970 oral solutionDRUGParticipants will receive a single oral dose \[14C\]GLPG3970.
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Eligibility Criteria
Age Range30 Years — 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF). * A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive. * Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day). This list onl...

Countries:United Kingdom
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