Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers

Sponsor
Genfit
Study ID
NCT04171752
Phase
PHASE1
Status
Completed

Conditions

  • Geriatrics
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • elafibranor — DRUG
    elafibranor 120mg is a coated tablet for oral administration

Study Details

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.

Key Dates

Start date
Nov 22, 2019
Status verified
Aug 2020
Primary completion
Mar 22, 2020
Completion
Mar 30, 2020

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Young Adults
    Single oral dose of elafibranor 120mg
  • Experimental: Elderly
    Single oral dose of elafibranor 120mg

Primary Outcome Measure

Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metabolite [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers ]

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