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GLPG1972 fasted

Phase 1

Osteoarthritis | Small molecule | Musculoskeletal |Galapagos NV|Last Updated: Oct 4, 2016

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02851485Bioavailability Study With GLPG1972PHASE1 COMPLETED 12Jul 1, 2016Aug 1, 2016Oct 4, 20161 Netherlands
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) of GLPG1972
From pre-dose (period 1) until 6 days after the last dose (period 3)

To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast

Plasma concentration of GLPG1972 24 hours after dosing
24 hours after each dose

To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast

The time of the occurrence of Cmax of GLPG1972
From pre-dose (period 1) until 6 days after the last dose (period 3)

To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast

The area under the plasma concentration versus time curve
From pre-dose until 6 days post-dose for each dosing period

To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast

The apparent terminal half-life of GLPG1972
From pre-dose (period 1) until 6 days after the last dose (period 3)

To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast

The number of adverse events reported
From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose

To evaluate safety and tolerability of single oral doses of GLPG1972

Changes in clinical laboratory evaluations
From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose

To evaluate safety and tolerability of single oral doses of GLPG1972

Changes in vital signs
From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose

To evaluate safety and tolerability of single oral doses of GLPG1972

Changes in physical examination parameters
From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose

To evaluate safety and tolerability of single oral doses of GLPG1972

Changes in ECG parameters
From pre-dose until the Follow up (FU) visit anticipated to take place 7-10 days after the last dose

To evaluate safety and tolerability of single oral doses of GLPG1972

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GLPG1972 600 mg oral solution fastedEXPERIMENTAL600 mg GLPG1972 administered as oral solution after overnight fasting
GLPG1972 600 mg oral tablet fastedEXPERIMENTAL600 mg GLPG1972 administered as oral tablet after overnight fasting
GLPG1972 600 mg oral tablet fedEXPERIMENTAL600 mg GLPG1972 administered as oral tablet after a high-fat high-calorie breakfast
Interventions
NameTypeDescription
GLPG1972 600 mg oral solution fastedDRUGdosing after overnight fasting
GLPG1972 600 mg oral tablet fastedDRUGdosing after overnight fasting
GLPG1972 600 mg oral tablet fedDRUGdosing after high-fat high-calorie breakfast
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male between 18 and 50 years of age, inclusive, on the day of signing the informed consent form (ICF). 2. A body mass index (BMI) between 18-30 kg/m², inclusive, with a weight of at least 50 kg. 3. Judged by the investigator to be in good health based upon the results of a me...

Countries:Netherlands
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