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

NCT04720183 | Completed Phase 1 FDA Drug

• 1 other identifier: GLPG3970-CL-117
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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 (3)

• 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

Study Arms (1)

Sulfasalazine + GLPG3970

EXPERIMENTAL

Drug: Sulfasalazine; Drug: GLPG3970

Interventions

Sulfasalazine DRUG

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

Sulfasalazine + GLPG3970

GLPG3970 DRUG

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

Sulfasalazine + GLPG3970

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Biotral Inc

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Interventions

Sulfasalazine

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Natalia Rueda-Rincon, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: January 11, 2021
• Primary Completion: April 21, 2021
• Study Completion: April 23, 2021
• Last Updated: September 19, 2024

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)