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Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers

NCT04171752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-08-13

No results posted yet for this study

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

DRUG

elafibranor

elafibranor 120mg is a coated tablet for oral administration

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Pascal Birman, MD · Genfit

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2020-03-22
Completion
2020-03-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171752 on ClinicalTrials.gov