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

Study Overview
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Brief Summary
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This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.

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

Official Title
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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)

Conditions
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Nonalcoholic Fatty Liver

Intervention / Treatment
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* Drug: PXL770
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PXL770<br>PXL770 500 mg once daily (QD) for 4 weeks | Drug: PXL770<br>* Oral capsule<br>Drug: Placebo<br>* Oral capsule<br>|
| Placebo Comparator: Placebo<br>placebo once daily (QD) for 4 weeks | Drug: PXL770<br>* Oral capsule<br>Drug: Placebo<br>* Oral capsule<br>|

What is the study measuring?
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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 |