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Effect of Alpelisib in Healthy Volunteers
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).
Details
| Lead sponsor | Columbia University |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 23 |
| Start date | Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Insulin Resistance
- Hyperinsulinemia
- Dyslipidemias
Interventions
- Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg)
- Placebo (microcrystalline cellulose), 2 capsules
- FreeStyle Libre Pro
- Oral glucose tolerance test (OGTT) with Trutol glucose beverage
- BOOST Plus nutritional beverage
Countries
United States