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

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)

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

Study Overview

• Status: Completed
• Conditions: Nonalcoholic Fatty Liver
• Intervention / Treatment: Drug: Placebo; Drug: PXL770

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • High Point, North Carolina, United States, 27265
      • High Point Clinical Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PXL770; PXL770 500 mg once daily (QD) for 4 weeks	Drug: Placebo; Oral capsule; Drug: PXL770; Oral capsule
Placebo Comparator: Placebo; placebo once daily (QD) for 4 weeks	Drug: Placebo; Oral capsule; Drug: PXL770; Oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of PXL770	AUC : Area under the plasma concentration curve	Day 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma PK parameters of PXL770	Minimum plasma concentration (Cmin)	Day 26
Plasma PK parameters of PXL770	Average plasma concentration (Cavg)	Day 26
Plasma PK parameters of PXL770	Time to maximum plasma concentration (Tmax)	Day 26
Plasma PK parameters of PXL770	Apparent volume of distribution (Vz/F)	Day 26
Plasma PK parameters of PXL770	Apparent oral drug clearance at steady state (CLss/F)	Day 26
Plasma PK parameters of PXL770	Elimination rate constant (λz)	Day 26
Plasma PK parameters of PXL770	Terminal elimination half-life (t½)	Day 26
Plasma PK parameters of PXL770	Area under the concentration-time curve from time 0 to last observed concentration (AUClast)	Day 26
Plasma PK parameters of PXL770	Food effect: Cmax	Day 14 and Day 26
Plasma PK parameters of PXL770	Food effect: AUCtau	Day 14 and Day 26
Plasma PK parameters of PXL770	Food effect: Tmax	Day 14 and Day 26
Plasma PK parameters of PXL770	PK profile during OGTT: AUCtau	Day 27
Plasma PK parameters of PXL770	PK profile during OGTT: Cmax	Day 27

Collaborators and Investigators

• Sponsor: Poxel SA

Publications and helpful links

General Publications

• Fouqueray P, Bolze S, Dubourg J, Hallakou-Bozec S, Theurey P, Grouin JM, Chevalier C, Gluais-Dagorn P, Moller DE, Cusi K. Pharmacodynamic effects of direct AMP kinase activation in humans with insulin resistance and non-alcoholic fatty liver disease: A phase 1b study. Cell Rep Med. 2021 Dec 21;2(12):100474. doi: 10.1016/j.xcrm.2021.100474. eCollection 2021 Dec 21.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): March 29, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: PXL770-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No