Randomized Phase 1 Study Comparing Absorption of Different Prifetrastat Tablet Forms in Healthy Adults

What this Trial Is About

This trial evaluates how different forms of the drug prifetrastat are absorbed into the bloodstream in healthy adults. It focuses on understanding how variations in the particle size of the active ingredient in prifetrastat tablets affect the drugs absorption, processing, and elimination by the body. The study is conducted in a phase 1 setting with healthy male and female participants who are not of childbearing potential. Participants will receive single oral doses of prifetrastat in tablet form from different product lots with varying particle sizes. The dosing sequence is randomized, and each participant will receive at least two doses with a minimum 14-day interval between them. The study uses a crossover design, meaning participants receive different forms of the drug in separate periods. Participants will remain in the study clinic for 21 days but may leave between dosing periods. During the study, blood samples will be collected at multiple time points up to 144 hours after each dose to measure drug concentration and pharmacokinetic parameters such as area under the plasma concentration-time profile AUC and maximum plasma concentration Cmax. Researchers will also monitor participants for treatment emergent adverse events and clinically significant changes in laboratory results, vital signs, ECGs, and physical exams up to 35 days after the last dose. There will be one follow-up contact after the study period to ensure participant safety.

A Study to Learn About How Different Forms of Study Medicine Prifetrastat Are Taken Up Into the Blood in Healthy Adults