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GLPG4716

Phase 1

Healthy | Small molecule | Other |Lakefront Biotherapeutics|Last Updated: Sep 19, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

GLPG4716 · 2 trials · 1 indication

Phase 1 2
NCT05030857Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy SubjectsHealthy
COMPLETED19 Analytics
NCT04971746Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy SubjectsHealthy
COMPLETED58 Analytics
PHASE1COMPLETED
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
Healthy
NCT0503085719
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PHASE1COMPLETED
Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects
Healthy
NCT0497174658
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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

Maximum observed plasma concentration (Cmax) of pirfenidone
From Day 1 pre-dose until Day 15

To determine the effect of GLPG4716 on the PK of pirfenidone

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

To determine the effect of GLPG4716 on the PK of pirfenidone

Cmax of nintedanib
From Day 1 pre-dose until Day 15

To determine the effect of GLPG4716 on the PK of nintedanib.

AUC0-inf of nintedanib
From Day 1 pre-dose until Day 15

To determine the effect of GLPG4716 on the PK of nintedanib.

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 -
GLPG4716 and pirfenidoneEXPERIMENTAL -
GLPG4716 and nintedanibEXPERIMENTAL -

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.
PirfenidoneDRUGOn Days 1 and 13, participants will receive an oral dose of pirfenidone.
NintedanibDRUGOn Days 1 and 13, participants will receive an oral dose of nintedanib.
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Eligibility Criteria

Age Range18 Years to 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:CanadaGermany
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