High Point Clinical Trials Center
High Point, North Carolina, 27265, United States
NCT Number: NCT03950882
This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
High Point, North Carolina, 27265, United States
The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral capsule
Oral capsule
Time frame: Day 26
AUC : Area under the plasma concentration curve
Time frame: Day 26
Minimum plasma concentration (Cmin)
Time frame: Day 26
Average plasma concentration (Cavg)
Time frame: Day 26
Time to maximum plasma concentration (Tmax)
Time frame: Day 26
Apparent volume of distribution (Vz/F)
Time frame: Day 26
Apparent oral drug clearance at steady state (CLss/F)
Time frame: Day 26
Elimination rate constant (λz)
Time frame: Day 26
Terminal elimination half-life (t½)
Time frame: Day 26
Area under the concentration-time curve from time 0 to last observed concentration (AUClast)
Time frame: Day 14 and Day 26
Food effect: Cmax
Time frame: Day 14 and Day 26
Food effect: AUCtau
Time frame: Day 14 and Day 26
Food effect: Tmax
Time frame: Day 27
PK profile during OGTT: AUCtau
Time frame: Day 27
PK profile during OGTT: Cmax
Poxel SA
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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