Effect of Alpelisib in Healthy Volunteers

Summary

The goal of this clinical trial is to test a single dose of the phosphoinositide-3-kinase (PI3K) inhibitor alpelisib versus placebo in healthy volunteers. The main questions it aims to answer are the impact of acute alpelisib-induced insulin resistance on parameters of glucose and lipid metabolism (how healthy people respond to temporary insulin resistance so that the investigators can see what happens to how the liver handles fat and sugar). Participants will: * Consume their total calculated daily caloric needs in nutritional supplements, divided in three meals, and otherwise fast for 24 hours * Take a dose of alpelisib 300 mg or placebo at bedtime * Wear a continuous glucose monitor for 72 hours * Participate in an oral glucose tolerance test (OGTT) Researchers will compare blood tests before and during OGTT in participants randomized (like the flip of a coin) to alpelisib versus placebo to see how the drug treatment affects plasma glucose, serum insulin, and serum lipid parameters (triglycerides, free fatty acids, and apolipoprotein B).

Timeline

Start

2023-05-09

Primary completion

2023-12-01

Completion

2023-12-01

Drugs

Indications