This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single center study, in three semi-sequential cohorts of 10 male and female subjects of nonchildbearing potential with Osteoarthritis (OA), administered GLPG1972 or placebo. Per cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with GLPG1972 or matching placebo. In each cohort, OA subjects will be stratified for age (50- 64 years and 65-75 years) with a minimum of 2 of each sex per age group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
GLPG1972 dose 1 provided as oral tablets q.d.
GLPG1972 dose 2 provided as oral tablets q.d.
GLPG1972 dose 3 provided as oral tablets q.d.
Covance Daytona Beach
Daytona Beach, Florida, United States
Difference between GLPG1972 treated subjects and placebo subjects in the number of Adverse Events
To assess safety and tolerability of GLPG1972 in OA patients
Time frame: From screening until the final follow up visit (day 50)
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal vital signs
To assess safety and tolerability of GLPG1972 in OA patients
Time frame: From screening until the final follow up visit (day 50)
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal clinical laboratory evaluations
To assess safety and tolerability of GLPG1972 in OA patients
Time frame: Screening, Days -1, 2, 4, 8, 9, 15, 22, 29, 43 and the final follow up visit (day 50)
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal physical examination
To assess safety and tolerability of GLPG1972 in OA patients
Time frame: Screening, days -1, 1, 2, 8, 15, 22, 29, 43 and the final follow up visit (day 50
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal ECG
To assess safety and tolerability of GLPG1972 in OA patients
Time frame: Screening, days 1, 2, 3, 4, 8, 15, 22, 29, 43 and the final follow up visit (day 50)
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal Holter assessment
To assess safety and tolerability of GLPG1972 in OA patients
Time frame: Day -1 to days 1 and Day 10 to day 11
The maximum observed plasma concentration of GLPG1972 (Cmax)
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Matching placebo provided as oral tablets q.d.
To assess PK of GLPG1972 in OA patients
Time frame: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
The time (tmax) to reach Cmax of GLPG1972
To assess PK of GLPG1972 in OA patients
Time frame: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
The plasma concentration of GLPG1972 24 after the last dose
To assess PK of GLPG1972 in OA patients
Time frame: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
The area under the plasma concentration time curve from time 0 until the last quantifieble dose
To assess PK of GLPG1972 in OA patients
Time frame: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
Percentage reduction of neo-epitope ARGS vs baseline
To assess PD of GLPE1972 in OA patients
Time frame: Days 1, 3, 6, 8, 10, 15, 22, 29, 43 and the final follow up visit (day 50)