Drug-drug Interaction Study With GLPG3970 and Sulfasalazine in Adult, Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Sulfasalazine; Drug: GLPG3970

• Registration Number: NCT04720183
• Lead Sponsor: Galapagos NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-11
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Primary Completion: 2021-04-21
• Study Completion: 2021-04-23
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sulfasalazine + GLPG3970	GLPG3970	-
Sulfasalazine + GLPG3970	Sulfasalazine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity	From Day 1 through study completion, an average of 1 month	To evaluate the safety and tolerability of the coadministration of GLPG3970 with sulfasalazine in healthy subjects
Maximum observed concentration (Cmax) of GLPG3970	Between Day 5 pre-dose and Day 10	To evaluate the PK of GLPG3970 in presence of sulfasalazine in healthy subjects
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	To evaluate the PK of GLPG3970 in presence of sulfasalazine in healthy subjects

Trial Locations

Locations (1)

Biotral Inc; 🇺🇸 Newark, New Jersey, United States