Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)

Part of paid clinical trials in San Diego, California.

Sponsor
Genfit
Study ID
NCT03883607
Phase
PHASE2
Status
Terminated

Conditions

  • Non Alcoholic Steatohepatitis

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Elafibranor 80mg — DRUG
    Once daily oral intake of elafibranor 80 mg during 3 months
  • Elafibranor 120mg — DRUG
    Once daily oral intake of elafibranor 120 mg during 3 months

Study Details

The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams \[mg\] and 120mg) during 3 months in children and adolescent population (8 to 17 years of age) with non alcoholic steatohepatitis (NASH).

Key Dates

Start date
Jun 25, 2019
Status verified
Sep 2021
Primary completion
Jun 16, 2020
Completion
Jun 16, 2020

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elafibranor 80 mg
    Participants received Elafibranor 80 mg tablet orally once daily for 12 weeks.
  • Experimental: Elafibranor 120 mg
    Participants received Elafibranor 120 mg tablet orally once daily for 12 weeks.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Elafibranor and Its Active Metabolite (GFT1007) [ Time Frame: Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administration ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan DiegoCalifornia92103-
Columbia UniversityNew YorkNew York10032-

Find similar trials in San Diego, CA

By research site
University of California· San Diego, CAColumbia University· New York, NY

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