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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Sulfasalazine; Drug: GLPG3970

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Biotral Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sulfasalazine + GLPG3970	Drug: Sulfasalazine; On Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.; Drug: GLPG3970; On Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	To evaluate the PK of GLPG3970 in presence of sulfasalazine in healthy subjects	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)	To evaluate the PK of GLPG3970 in presence of sulfasalazine in healthy subjects	Between Day 5 pre-dose and Day 10

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Natalia Rueda-Rincon, MD, Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): April 23, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Sulfasalazine
• Other Study ID Numbers: GLPG3970-CL-117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No