The purpose of this study is to characterize the disruption of intestinal barrier as a result of indomethacin challenge in healthy volunteers using an orally administered lactulose-mannitol test.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
Indomethacin capsules will be administered orally.
Lactulose-mannitol solution will be administered orally.
Clinical Pharmacology Unit
Merksem, Belgium
Longitudinal Change From Baseline in Lactulose/Mannitol Ratio in the Urine Following Indomethacin Challenge
Longitudinal change from baseline in L/M ratio in the urine following indomethacin challenge will be assessed. L/M ratio in urine is a useful and noninvasive marker for the evaluation of intestinal permeability in the urinary excretion of these nonmetabolized sugars.
Time frame: Baseline, Up to 14 days
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time frame: Up to 6 weeks
Number of Participants with Treatment-Emergent Serious Adverse Events (TE-SAEs)
TE-SAEs is defined as any untoward medical occurrence with a reasonable possibility that it is caused by the study intervention that: Is life-threatening (example; leads to stroke or non-fatal pulmonary embolism); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in other clinically significant sign(s) or symptom(s), (example; clinically asymptomatic brain microhemorrhages); or Results in death.
Time frame: Up to 6 weeks
Longitudinal Change From Baseline in Selected Biomarkers Following Indomethacin Challenge
Change from baseline in selected biomarkers levels (example: Lactulose-mannitol, C-reactive protein \[CRP\], calprotectin, Et cetera \[etc.\]) using analysis methods such as liquid chromatography/mass spectrometry, immunoturbidimetry, enzyme-linked immunosorbent assay (ELISA), etc., as a result of the indomethacin challenge.
Time frame: Baseline, Up to 14 days
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