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

Nonalcoholic Fatty Liver Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950882
• Other study ID #: PXL770-003
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2021
• Source: Poxel SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 31, 2020
• Est. primary completion date: March 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver

Intervention

Drug:
• PXL770
Oral capsule
• Placebo
Oral capsule

Locations

Country	Name	City	State
United States	High Point Clinical Trials Center	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Poxel SA

Country where clinical trial is conducted

United States, 

Outcome

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