The purpose of Part 1 of this First-in-Human trial is to evaluate the safety and tolerability after single ascending oral doses of IOA-289 given to healthy male subjects, compared to placebo. After the oral dose administrations, the amount of IOA-289 present in serum will be determined for pharmacokinetic characterisation. Also the reduction of LPA in plasma will be determined as a pharmacodynamic biomarker. Part 2 is optional and its conduct will be dependent on the pharmacokinetic data generated in Part 1. Part 2 will be a randomized, crossover, open label, single oral dose administration of IOA-289 to healthy male subjects either in a fasted state, or after a high-fat meal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Daily oral twice daily dosing of IOA-289
Given in combination with IOA-289
Centro Ricerche Cliniche di Verona srl
Verona, Verona, Italy
Numbers of participants with treatment-related adverse events as assessed by MedDRA v24
Adverse Events will be assessed by nondirective questioning of the participants during the screening process and at each visit during the study
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Pharmacokinetic profile of IOA-289
Blood samples for plasma IOA-289 concentrations
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Cmax
The maximum observed plasma concentration
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Tmax
The time at which Cmax occurs
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
AUCinf
The area under the plasma concentration-time curve from time of dosing to infinity
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
To determine the change from baseline of LPA levels
Measurement of LPA levels in plasma
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
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