Phase 1 Open-Label Crossover Study Comparing Two Oral Forms of Varegacestat in Healthy Adults

What this Trial Is About

Researchers are evaluating the relative bioavailability and bioequivalence of two capsule formulations of varegacestat in healthy adult participants aged 18 to 55 years. This open-label, randomized crossover Phase 1 study aims to compare how the body absorbs and processes the test capsule formulation versus the reference capsule under fasting conditions. Participants will receive varegacestat orally in two different forms a reference formulation and a test formulation. They will be randomly assigned to receive either the reference formulation followed by the test formulation or vice versa. The study includes a crossover design, allowing each participant to serve as their own control while assessing drug absorption and peak concentration. During the approximately three-week study period, participants will undergo various assessments including measurements of drug concentration over time AUC0-t, AUC0-inf and peak drug level Cmax. Safety and tolerability will also be monitored through reports of adverse events, laboratory tests, vital signs, and ECGs. The total participation duration is around three to four weeks, with careful monitoring to ensure participant well-being throughout the study.

A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants