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

NCT ID: NCT04720183

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2021-04-23

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sulfasalazine + GLPG3970

Group Type: EXPERIMENTAL

Sulfasalazine

Intervention Type: DRUG

On Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.

GLPG3970

Intervention Type: DRUG

On Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state.

Interventions

Sulfasalazine

On Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.

Intervention Type: DRUG

GLPG3970

On Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state.

Intervention Type: DRUG

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia Rueda-Rincon, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Biotral Inc

Newark, New Jersey, United States

Countries

United States

Other Identifiers

GLPG3970-CL-117

Identifier Type: -

Identifier Source: org_study_id