The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after single oral dosing.
The study is a single-centre, double-blind, randomized, placebo-controlled, parallel group phase I study with healthy male subjects receiving ascending single oral oral doses of Px-102 to assess the safety and tolerability, pharmacokinetics and pharmacodynamics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
FOCUS Clinical Drug Development GmbH
Neuss, Germany
Safety and tolerability of Px-102
Adverse event monitoring, laboratory values, cardiovascular monitoring. Comparison of active vs. placebo
Time frame: 24h
Pharmacokinetics of Px-102 and metabolites
Plasma, Urine and fecal concentrations (ng/mL) of Px-102 and metabolites measured by LC-MS/MS. AUC, Cmax and other pk parameters, dose proportionality
Time frame: pre-dose (0 hours), 15 min, 30 min, 1, 1.5, 2, 4, 6, 8, 12, 24 hours after dosing
Pharmacodynamics
Markers for FXR activation (e.G. FGF19 concentrations (pg/mL) measured by ELISA); comparison active vs. placebo
Time frame: pre-dose (0 hours) and 1, 2, 4, 8, 12, and 24 hours
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