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

• Status: Completed
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poxel SA

Criteria

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