Recent Updates
Recently added Catalysts

GLPG1205 q.d.

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Apr 5, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03102567This is a Study to Evaluate the Effect of Aging of Multiple Doses of GLPG1205 in Healthy SubjectsPHASE1 COMPLETED 32 — — Oct 18, 2016Feb 13, 2017Apr 5, 20171 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Difference between the number of healthy male subjects from different age groups and placebo subjects with adverse events
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal laboratory evaluations
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal vital signs
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal ECG
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal physical examination
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between healthy male subjects of different age groups of Cmax of GLPG1205
From day 1 pre-dose until the final follow up visit (day 35)

To assess PK of GLPG1205 in the first part of the study with different age groups

Difference between healthy male subjects of different age groups of tmax of GLPG1205
From day 1 pre-dose until the final follow up visit (day 35)

To assess PK of GLPG1205 in the first part of the study with different age groups

Difference between healthy male subjects of different age groups of AUC0-t of GLPG1205
From day 1 pre-dose until the final follow up visit (day 35)

To assess PK of GLPG1205 in the first part of the study with different age groups

Difference between healthy male subjects of different age groups of apparent terminal half-life (t1/2) of GLPG1205
From day 1 pre-dose until the final follow up visit (day 35)

To assess PK of GLPG1205 in the first part of the study with different age groups

Assessment of Cmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
From day 1 pre-dose until the final follow up visit (day 35)

In the open label (part 2) of the study

Assessment of tmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
From day 1 pre-dose until the final follow up visit (day 35)

In the open label (part 2) of the study

Assessment of AUC0-t of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
From day 1 pre-dose until the final follow up visit (day 35)

In the open label (part 2) of the study

Assessment of t1/2 of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
From day 1 pre-dose until the final follow up visit (day 35)

In the open label (part 2) of the study

Secondary Endpoints
Assessment of creatinine clearance in healthy elderly subjects
From screening until the final follow up visit (day 35)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GLPG1205 50mg q.d.EXPERIMENTALoral hard gelatin capsules with 50 mg GLPG1205 for q.d. administration - compared to placebo
placeboPLACEBO_COMPARATORoral hard gelatin capsules containing placebo for q.d. administration
GLPG1205 250 mg loading and 50mg q.d. maintenanceEXPERIMENTALopen label - oral hard gelatin capsules with 50 mg GLPG1205 for one time 250 mg loading dose and subsequent 50mg q.d. administration
Interventions
NameTypeDescription
GLPG1205 50mg q.d.DRUGoral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo
Placebo oral capsuleDRUGoral gelatin capsule containing placebo to match study arm 1 - q.d. administration
GLPG1205 250 loading dose and 50mg q.d. maintenance doseDRUGOpen label - oral gelatin capsule containing 50mg GLPG1205 for one time 250mg loading dose and subsequent q.d. administration
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male, aged over 18 years 2. Able and willing to sign the ICF. 3. Able and willing to comply with the requirements of the study. 4. Body Mass Index (BMI) between 18 and 30 kg/m² inclusive. 5. Weight between 60 and 90 kg, inclusive (Cohort A only). 6. Considered by the Investig...

Countries:Belgium
Unlock Eligibility Criteria