NCT04171752

Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Geriatrics
• Healthy

Interventions

Type	Name	Description
DRUG	elafibranor	elafibranor 120mg is a coated tablet for oral administration

Timeline

• Start date: 2019-11-22
• Primary completion: 2020-03-22
• Completion: 2020-03-30
• First posted: 2019-11-21
• Last updated: 2020-08-13

Locations

1 site across 1 country: France