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Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers

Healthy Clinical Trial

Official title:
Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Healthy Elderly and Young Adults Volunteers

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04171752
Study type Interventional
Source Genfit
Contact
Status Completed
Phase Phase 1
Start date November 22, 2019
Completion date March 30, 2020
View Details
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