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

Healthy Clinical Trial

Official title:

A Phase 1, Fixed Sequence, Open-label, Drug-drug Interaction Study to Evaluate the Effect of GLPG3970 on the Pharmacokinetics of Sulfasalazine in Adult, Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720183
• Other study ID #: GLPG3970-CL-117
• Status: Completed
• Phase: Phase 1
• Start date: January 11, 2021
• Est. completion date: April 23, 2021

Study information

• Verified date: July 2021
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 23, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Sulfasalazine
On Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.
• GLPG3970
On Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state.

Locations

Country	Name	City	State
United States	Biotral Inc	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Maximum observed concentration (Cmax) of GLPG3970	To evaluate the PK of GLPG3970 in presence of sulfasalazine in healthy subjects	Between Day 5 pre-dose and Day 10
Secondary	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	Between Day 5 pre-dose and Day 10