NCT05027568

A Study to Assess an ATX Inhibitor (IOA-289) in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: iOnctura · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IOA-289	Daily oral twice daily dosing of IOA-289
DRUG	Nab paclitaxel / gemcitabine	Given in combination with IOA-289

Timeline

• Start date: 2021-06-28
• Primary completion: 2021-09-07
• Completion: 2021-09-07
• First posted: 2021-08-30
• Last updated: 2025-03-20

Locations

1 site across 1 country: Italy