Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers
Status:
Completed
Trial end date:
2020-03-30
Target enrollment:
Participant gender:
Summary
In the elderly, pharmacokinetics is altered. Gastric juice pH is elevated which influences
drug solubility and absorption. Drug distribution is decreased in the elderly because of
decreased cardiac output, increased peripheral vascular resistance, diminished blood flow in
the liver and the kidneys, reduced total amount of water in the body. Drug metabolism and
biotransformation mainly take place in the liver and is often reduced. Drug elimination is
altered very often because of reduced excretory (renal and hepatic) function. All these
changes may lead to significant pharmacokinetic changes in geriatric population. A formal
pharmacokinetic clinical study is being conducted in order to assess the need of dose
adjustment in the elderly population.