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GLPG4399

Phase 1

Healthy | Small molecule | Other |Lakefront Biotherapeutics|Last Updated: Feb 1, 2022

Target and mechanism

ModalitySmall molecule

Also known as GLPG4399 oral suspension

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

GLPG4399 · 1 trial · 1 indication

Phase 1 1
NCT04653467A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult SubjectsHealthy
COMPLETED88 Analytics
PHASE1COMPLETED
A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult Subjects
Healthy
NCT0465346788
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Study Endpoints

Primary Endpoints

Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
From screening through study completion, an average of 6 months

To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG4399 in adult, healthy, male subjects.

Secondary Endpoints

Maximum observed plasma concentration (Cmax) of GLPG4399
Between Day 1 pre-dose and Day 33
Area under curve (AUC) of GLPG4399
Between Day 1 pre-dose and Day 33
Terminal elimination half-life (t1/2) of GLPG4399
Between Day 1 pre-dose and Day 33
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
GLPG4399 SADEXPERIMENTALSingle doses of GLPG4399 at up to 6 dose levels in ascending order
Placebo SADPLACEBO_COMPARATORSingle doses of placebo
GLPG4399 MADEXPERIMENTALMultiple ascending doses of GLPG4399
Placebo MADPLACEBO_COMPARATORMultiple doses of placebo
GLPG4399 FE-rBAEXPERIMENTALSingle dose of GLPG4399 in fed and fasted state
GLPG4399 FEEXPERIMENTALSingle dose of GLPG4399 in fed and fasted state

Interventions

NameTypeDescription
GLPG4399 oral suspensionDRUGGLPG4399 for oral administration
GLPG4399 capsulesDRUGGLPG4399 for oral administration
PlaceboDRUGPlacebo oral suspension
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Eligibility Criteria

Age Range18 Years to 54 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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

Countries:Canada
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