Centro Ricerche Cliniche di Verona srl
Verona, 37134, Italy
NCT Number: NCT05027568
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.
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Notify Me18 year–50 year
Male
Interventional
Phase 1
Verona, 37134, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily oral twice daily dosing of IOA-289
Given in combination with IOA-289
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
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
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
The maximum observed plasma concentration
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
The time at which Cmax occurs
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
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
Measurement of LPA levels in plasma
iOnctura
Industry
Randomized, Double-blind, Placebo-controlled, Dose Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of IOA-289 in Healthy Male Volunteers
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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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