Drug-drug Interaction Study with GLPG3970 and Sulfasalazi... | NCT04720183

NCT04720183

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Sulfasalazine + GLPG3970	Experimental		Drug: Sulfasalazine Drug: GLPG3970

Name	Type	Description	Arm Group Labels	Other Names
Sulfasalazine	Drug	On Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.	Sulfasalazine + GLPG3970

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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.	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.	Between Day 1 pre-dose and Day 12

Secondary Outcomes

Measure	Description	Time Frame
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	From Day 1 through study completion, an average of 1 month
Maximum observed concentration (Cmax) of GLPG3970

Eligibility Module

Eligibility Criteria

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 (BCRP) c421C/C genotype.
Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to the first sulfasalazine administration. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

Known hypersensitivity to the investigational product (IP) (GLPG3970), or sulfasalazine, or sulfa drugs, or to their ingredients, or history of a significant allergic reaction to IP or sulfasalazine ingredients as determined by the investigator.
Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of sulfasalazine.
History of or a current immunosuppressive condition (e.g. human immunodeficiency virus (HIV) infection).
Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of sulfasalazine.
Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate (eGFR) <=90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
Subjects with an N-acetyltransferase 2 (NAT2) slow acetylator genotype.

This list only contains the key exclusion criteria.