Pharmacokinetic Study to Evaluate Dabigatran Etexilate in Elderly Subjects (NCT05715658) | Clinical Trial Compass
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Pharmacokinetic Study to Evaluate Dabigatran Etexilate in Elderly Subjects
China36 participantsStarted 2022-08-15
Plain-language summary
This study intends to collect blood samples of adult healthy subjects, elderly healthy subjects and elderly patients with atrial fibrillation after taking dabigatran etexilate for pharmacokinetics and other studies, aiming to reveal the effect of dabigatran etexilate in Chinese elderly population. Pharmacokinetic profile and biomarker concentration levels; fecal samples were collected for gut microbiota studies to further explore potential mechanisms. The results of the study may provide reference for the precision medicine of dabigatran etexilate and other drugs in the elderly population or the development of new clinical drugs.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. With full capacity for civil conduct, the age of adult healthy subjects is ≥18 years old and ≤30 years old; elderly healthy subjects ≥ 75 years old; elderly patients with atrial fibrillation are ≥75 years old.
✓. Male weight ≥ 50 kg, female weight ≥ 45 kg; body mass index (BMI) within the range of 19.0\~27.0 (including upper and lower limits), body mass index (BMI) = weight (kg) / height 2 (m2).
✓. Creatinine clearance rate (CRCL): calculated by Cock Croft-Gault equation, adult healthy subjects should have CRCL≥90mL/min; elderly healthy subjects should have CRCL≥60mL/min; elderly patients with atrial fibrillation should have CRCL≥30mL/min.
✓. Elderly patients with atrial fibrillation should have meet the diagnostic criteria for non-valvular atrial fibrillation.
✓. Elderly patients with atrial fibrillation are taking Dabigatran etexilate for routine treatment.
Exclusion criteria
✕. History of fainting of needles and blood.
✕. Diseases affecting intestinal P-glycoprotein: severe diarrhea (excretion more than 3 times a day with watery stool characteristics), Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulitis, difficult Identify Clostridium infection (recurrent) or Helicobacter pylori infection.
What they're measuring
1
Concentration in plasma of dabigatran on the first day before administration
Timeframe: on the first 1 day before administration
2
Concentration in plasma of dabigatran on the 2, 6, 10, and 24 hours after administration
Timeframe: on the 2, 6, 10, and 24 hours after administration
3
Species of intestinal flora
Timeframe: on the first 1 day before administration
✕. Diseases affecting the activity of CYP3A in the liver: acute kidney injury, liver cirrhosis, liver abscess, liver cancer, intrahepatic bile duct stones, etc.
✕. History of major diseases or newly discovered diseases: prostate cancer, leukemia, liver cancer, breast cancer, colorectal cancer, leukemia and other tumor diseases.
✕. Diseases or conditions with significant risk of major bleeding, such as current or recent peptic ulcer, malignant neoplasms with high bleeding risk, recent brain or spinal cord injury, recent brain, spinal cord, or eye surgery, recent intracranial hemorrhage, known or suspected Esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracranial vascular abnormalities.
✕. Clinically significant active bleeding.
✕. Are using anticoagulant drugs such as unfractionated heparin (UFH), low molecular weight heparin (LMWH) and heparin derivatives (fondaparinux sodium), vitamin K antagonists, rivaroxaban or other direct thrombin Inhibitors (recombinant hirudin, bivalirudin); thrombolytic drugs; or current use of antiplatelet aggregation drugs such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, dextran, sulfinpyrazone, aspirin, etc.