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Sulfasalazine

Phase 1

Healthy | Small molecule | Other |Galapagos NV|Last Updated: Sep 19, 2024

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04720183Drug-drug Interaction Study with GLPG3970 and Sulfasalazine in Adult, Healthy SubjectsPHASE1 COMPLETED 8Jan 11, 2021Apr 23, 2021Sep 19, 20241 United States
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Study Endpoints
Primary Endpoints
Maximum observed concentration (Cmax) of sulfasalazine
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

Cmax of sulfapyridine
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of sulfasalazine
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

AUC0-inf of sulfapyridine
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

Sulfapyridine to sulfasalazine AUC ratio
Between Day 1 pre-dose and Day 12

To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.

Secondary Endpoints
Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
From Day 1 through study completion, an average of 1 month
Maximum observed concentration (Cmax) of GLPG3970
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)
Between Day 5 pre-dose and Day 10
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Sulfasalazine + GLPG3970EXPERIMENTAL -
Interventions
NameTypeDescription
SulfasalazineDRUGOn Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.
GLPG3970DRUGOn Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Females should be of non-childbearing potential. * A body mass index (BMI) between 18.0 to 30.0 kg/m2, inclusive. * A breast cancer resistance protein (BC...

Countries:United States
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