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GLPG1690 film-coated

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Feb 15, 2019

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 Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03787186A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Given by Mouth and Into a Vein as an InjectionPHASE1 COMPLETED 8 — — Nov 9, 2018Jan 17, 2019Feb 15, 20191 United Kingdom
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Study Endpoints
Primary Endpoints
Change of total radioactivity excreted in urine and feces combined (µg) from baseline at Day 10 (Part 2)
From Day 1 pre-dose up to Day 10

To assess the mass balance using \[14C\]-GLPG1690.

Maximum observed plasma concentration (Cmax) of total radioactivity (Part 2).
From Day 1 pre-dose up to Day 10

To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma

Maximum observed plasma concentration (Cmax) of GLPG1690 (Part 2).
From Day 1 pre-dose up to Day 10

To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma

Area under the plasma concentration-time curve (AUC) of total radioactivity (Part 2).
From Day 1 pre-dose up to Day 10

To assess the PK of GLPG1690 and its main metabolites in plasma

Area under the plasma concentration-time curve (AUC) of GLPG1690 (Part 2).
From Day 1 pre-dose up to Day 10

To assess the PK of GLPG1690 and its main metabolites in plasma

Change in amount of [14C] GLPG1690 excreted in urine and feces combined (µg) from baseline at Day 7 (Part 2).
From Day 1 pre-dose up to Day 7

To better characterize the elimination pathways and metabolite profile of GLPG1690

Secondary Endpoints
Intravenous (IV) maximum observed plasma concentration (Cmax) of [14C]-GLPG1690 microtracer (MT) (Part 1).
From Day 1 pre-dose up to Day 4
Intravenous (IV) maximum observed plasma concentration (Cmax) of total radioactivity (Part 1).
From Day 1 pre-dose up to Day 4
IV Area under the plasma concentration-time curve (AUC) of [14C]-GLPG1690 microtracer (MT) (Part 1).
From Day 1 pre-dose up to Day 4
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
GLPG1690 oral and IVEXPERIMENTALGLPG1690 film-coated tablets followed by \[14C\]-GLPG1690 solution for infusion
[14C]-GLPG1690 capsulesEXPERIMENTAL\[14C\]-GLPG1690 capsules
Interventions
NameTypeDescription
GLPG1690 film-coated tabletsDRUGa single oral dose of GLPG1690
[14C]-GLPG1690 solution for infusionDRUGa 15-minute IV infusion \[14C\]-GLPG1690
[14C]-GLPG1690 capsulesDRUGsingle oral dose of \[14C\]-GLPG1690
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Eligibility Criteria
Age Range30 Years — 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Able and willing to comply with the clinical study protocol (CSP) requirements and sign the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC), before any screening evaluations. * Male subjects between 30 to 64 years of age (extremes included), o...

Countries:United Kingdom
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