A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD
- Registration Number
- NCT03950882
- Lead Sponsor
- Poxel SA
- Brief Summary
This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PXL770 PXL770 PXL770 500 mg once daily (QD) for 4 weeks PXL770 Placebo PXL770 500 mg once daily (QD) for 4 weeks Placebo PXL770 placebo once daily (QD) for 4 weeks Placebo Placebo placebo once daily (QD) for 4 weeks
- Primary Outcome Measures
Name Time Method PK parameters of PXL770 Day 26 AUC : Area under the plasma concentration curve
- Secondary Outcome Measures
Name Time Method Plasma PK parameters of PXL770 Day 27 PK profile during OGTT: Cmax
Trial Locations
- Locations (1)
High Point Clinical Trials Center
🇺🇸High Point, North Carolina, United States