Effect of Alpelisib in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

May 9, 2023

Primary Completion Date

December 1, 2023

Study Completion Date

December 1, 2023

Conditions
Insulin ResistanceHyperinsulinemiaDyslipidemias
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.

Trial Locations (1)

10032

Columbia University Irving Medical Center, New York

All Listed Sponsors
lead

Columbia University

OTHER

NCT05733455 - Effect of Alpelisib in Healthy Volunteers | Biotech Hunter | Biotech Hunter