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).

Conditions

• Insulin Resistance
• Hyperinsulinemia
• Dyslipidemias

Interventions

DRUG

Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg)

Participants will ingest two overencapsulated tablets of alpelisib at 23:00, along with a saltine cracker.

DRUG

Placebo (microcrystalline cellulose), 2 capsules

Participants will ingest two capsules filled with microcrystalline cellulose at 23:00, along with a saltine cracker.

DEVICE

FreeStyle Libre Pro

Continuous glucose monitoring for 24 hours (double blinded)

DIAGNOSTIC_TEST

Oral glucose tolerance test (OGTT) with Trutol glucose beverage

Participants will drink Trutol glucose beverage (D-glucose 75 g in 10 fl oz) and blood will be sampled at baseline and at 15, 30, 60, 90, 120, 150, and 180 minutes.

DIETARY_SUPPLEMENT

BOOST Plus nutritional beverage

Participants will consume a quantity of BOOST Plus calculated to match their daily caloric needs, divided over three liquid meals.

Sponsors & Collaborators

• Columbia University

  lead OTHER

Principal Investigators

• Joshua R Cook, MD, PhD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-09

Primary Completion

2023-12-01

Completion

2023-12-01

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations