drugset / Trial / NCT05027568
A Study to Assess an ATX Inhibitor (IOA-289) in Healthy Volunteers
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-06-28
- Primary completion
- 2021-09-07
- Completion
- 2021-09-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CAMBRITAXESTAT | Small molecule | — | Oral |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Nab-paclitaxel | Small molecule | — | — |
Indications
No indication recorded.