Clinical trial NCT03950882: A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nonalcoholic Fatty Liver
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2019-05-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: PK parameters of PXL770
timeFrame: Day 26
Secondary outcomes:
measure: Plasma PK parameters of PXL770
timeFrame: Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 14 and Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 14 and Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 14 and Day 26
measure: Plasma PK parameters of PXL770
timeFrame: Day 27
measure: Plasma PK parameters of PXL770
timeFrame: Day 27
Other outcomes:
Locations:
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
Study officials:
References:
citation: 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.