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Completed

NCT Number: NCT03950882

A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD

This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

About this study

The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects have given written informed consent
  • Body mass index (BMI): ≥ 25 kg/m²
  • Hepatic steatosis (CAP ≥ 300)
  • Insulin-resistant but not diabetic subjects
  • Fasting plasma glucose <126 mg/dL
  • Glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73 m²]
  • Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males
  • Effective contraception

Exclusion criteria

  • Evidence of another form of liver disease
  • Evidence of liver cirrhosis
  • Evidence of hepatic impairment
  • Positive serologic evidence of current infectious liver disease
  • History of excessive alcohol intake
  • Acute cardiovascular disease with 24 weeks prior to screening
  • Uncontrolled high blood pressure
  • Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
  • Use of non-permitted concomitant medication
  • Pregnancy or lactation

Treatment and study plan

PXL770

Drug

Oral capsule

Placebo

Drug

Oral capsule

Primary outcomes

  1. PK parameters of PXL770

    Time frame: Day 26

    AUC : Area under the plasma concentration curve

Secondary outcomes

  1. Plasma PK parameters of PXL770

    Time frame: Day 26

    Minimum plasma concentration (Cmin)

  2. Plasma PK parameters of PXL770

    Time frame: Day 26

    Average plasma concentration (Cavg)

  3. Plasma PK parameters of PXL770

    Time frame: Day 26

    Time to maximum plasma concentration (Tmax)

  4. Plasma PK parameters of PXL770

    Time frame: Day 26

    Apparent volume of distribution (Vz/F)

  5. Plasma PK parameters of PXL770

    Time frame: Day 26

    Apparent oral drug clearance at steady state (CLss/F)

  6. Plasma PK parameters of PXL770

    Time frame: Day 26

    Elimination rate constant (λz)

  7. Plasma PK parameters of PXL770

    Time frame: Day 26

    Terminal elimination half-life (t½)

  8. Plasma PK parameters of PXL770

    Time frame: Day 26

    Area under the concentration-time curve from time 0 to last observed concentration (AUClast)

  9. Plasma PK parameters of PXL770

    Time frame: Day 14 and Day 26

    Food effect: Cmax

  10. Plasma PK parameters of PXL770

    Time frame: Day 14 and Day 26

    Food effect: AUCtau

  11. Plasma PK parameters of PXL770

    Time frame: Day 14 and Day 26

    Food effect: Tmax

  12. Plasma PK parameters of PXL770

    Time frame: Day 27

    PK profile during OGTT: AUCtau

  13. Plasma PK parameters of PXL770

    Time frame: Day 27

    PK profile during OGTT: Cmax

Sponsors and collaborators

Lead sponsor

Poxel SA

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 15, 2019
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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