Status:
COMPLETED
Drug-drug Interaction Study with GLPG3970 and Sulfasalazine in Adult, Healthy Subjects
Lead Sponsor:
Galapagos NV
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 subj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04720183
Start Date
January 11 2021
End Date
April 23 2021
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Biotral Inc
Newark, New Jersey, United States, 07103