Status:
COMPLETED
A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects
Lead Sponsor:
Galapagos NV
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 ...
Eligibility Criteria
Inclusion
- Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
- A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
- 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 randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and serum creatinine must be no greater than the upper limit of normal (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.
- Subject must be able and willing to comply with restrictions on prior and concomitant medication.
- Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.
- This list only contains the key inclusion criteria.
Exclusion
- Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP 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 the IP.
- 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 the IP.
- 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.
- This list only contains the key exclusion criteria.
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04856358
Start Date
April 27 2021
End Date
November 8 2021
Last Update
September 19 2024
Active Locations (1)
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1
Charité Research Organisation GmbH
Berlin, Germany, 10117