GLPG3970 will be given with sulfasalazine to investigate the effect of co-administration on the pharmacokinetics of sulfasalazine, and on the safety and tolerability of the drugs in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
On Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.
On Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state.
Biotral Inc
Newark, New Jersey, United States
Maximum observed concentration (Cmax) of sulfasalazine
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Time frame: Between Day 1 pre-dose and Day 12
Cmax of sulfapyridine
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Time frame: Between Day 1 pre-dose and Day 12
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of sulfasalazine
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Time frame: Between Day 1 pre-dose and Day 12
AUC0-inf of sulfapyridine
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Time frame: Between Day 1 pre-dose and Day 12
Sulfapyridine to sulfasalazine AUC ratio
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Time frame: Between Day 1 pre-dose and Day 12
Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
To evaluate the safety and tolerability of the coadministration of GLPG3970 with sulfasalazine in healthy subjects
Time frame: From Day 1 through study completion, an average of 1 month
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Maximum observed concentration (Cmax) of GLPG3970
To evaluate the PK of GLPG3970 in presence of sulfasalazine in healthy subjects
Time frame: Between Day 5 pre-dose and Day 10
Area under the plasma concentration-time curve from time zero till the last observed quantifiable concentration (AUC0-t)
To evaluate the PK of GLPG3970 in presence of sulfasalazine in healthy subjects
Time frame: Between Day 5 pre-dose and Day 10