search
Back to results

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

Primary Purpose

Nonalcoholic Fatty Liver

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PXL770
Placebo
Sponsored by
Poxel SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • High Point Clinical Trials Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PXL770

Placebo

Arm Description

PXL770 500 mg once daily (QD) for 4 weeks

placebo once daily (QD) for 4 weeks

Outcomes

Primary Outcome Measures

PK parameters of PXL770
AUC : Area under the plasma concentration curve

Secondary Outcome Measures

Plasma PK parameters of PXL770
Minimum plasma concentration (Cmin)
Plasma PK parameters of PXL770
Average plasma concentration (Cavg)
Plasma PK parameters of PXL770
Time to maximum plasma concentration (Tmax)
Plasma PK parameters of PXL770
Apparent volume of distribution (Vz/F)
Plasma PK parameters of PXL770
Apparent oral drug clearance at steady state (CLss/F)
Plasma PK parameters of PXL770
Elimination rate constant (λz)
Plasma PK parameters of PXL770
Terminal elimination half-life (t½)
Plasma PK parameters of PXL770
Area under the concentration-time curve from time 0 to last observed concentration (AUClast)
Plasma PK parameters of PXL770
Food effect: Cmax
Plasma PK parameters of PXL770
Food effect: AUCtau
Plasma PK parameters of PXL770
Food effect: Tmax
Plasma PK parameters of PXL770
PK profile during OGTT: AUCtau
Plasma PK parameters of PXL770
PK profile during OGTT: Cmax

Full Information

First Posted
May 13, 2019
Last Updated
June 8, 2021
Sponsor
Poxel SA
search

1. Study Identification

Unique Protocol Identification Number
NCT03950882
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 29, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poxel SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PXL770
Arm Type
Experimental
Arm Description
PXL770 500 mg once daily (QD) for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo once daily (QD) for 4 weeks
Intervention Type
Drug
Intervention Name(s)
PXL770
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
PK parameters of PXL770
Description
AUC : Area under the plasma concentration curve
Time Frame
Day 26
Secondary Outcome Measure Information:
Title
Plasma PK parameters of PXL770
Description
Minimum plasma concentration (Cmin)
Time Frame
Day 26
Title
Plasma PK parameters of PXL770
Description
Average plasma concentration (Cavg)
Time Frame
Day 26
Title
Plasma PK parameters of PXL770
Description
Time to maximum plasma concentration (Tmax)
Time Frame
Day 26
Title
Plasma PK parameters of PXL770
Description
Apparent volume of distribution (Vz/F)
Time Frame
Day 26
Title
Plasma PK parameters of PXL770
Description
Apparent oral drug clearance at steady state (CLss/F)
Time Frame
Day 26
Title
Plasma PK parameters of PXL770
Description
Elimination rate constant (λz)
Time Frame
Day 26
Title
Plasma PK parameters of PXL770
Description
Terminal elimination half-life (t½)
Time Frame
Day 26
Title
Plasma PK parameters of PXL770
Description
Area under the concentration-time curve from time 0 to last observed concentration (AUClast)
Time Frame
Day 26
Title
Plasma PK parameters of PXL770
Description
Food effect: Cmax
Time Frame
Day 14 and Day 26
Title
Plasma PK parameters of PXL770
Description
Food effect: AUCtau
Time Frame
Day 14 and Day 26
Title
Plasma PK parameters of PXL770
Description
Food effect: Tmax
Time Frame
Day 14 and Day 26
Title
Plasma PK parameters of PXL770
Description
PK profile during OGTT: AUCtau
Time Frame
Day 27
Title
Plasma PK parameters of PXL770
Description
PK profile during OGTT: Cmax
Time Frame
Day 27

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
High Point Clinical Trials Center
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35028615
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs