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NCT05733455 · ClinicalTrials.gov registry record · Phase 1
Effect of Alpelisib in Healthy Volunteers
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT05733455: Completed Phase 1 study, sponsored by Columbia University.
NCT05733455 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05733455, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study 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).
Primary Outcome
Fasting plasma glucose (units: mg/dL) after a single dose of alpelisib vs placebo.
Interventions
- DRUG Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg)
- DRUG Placebo (microcrystalline cellulose), 2 capsules
- DEVICE FreeStyle Libre Pro
- DIAGNOSTIC_TEST Oral glucose tolerance test (OGTT) with Trutol glucose beverage
- DIETARY_SUPPLEMENT BOOST Plus nutritional beverage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-05-09 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 1 |
What the finished NCT05733455 record still lists
NCT05733455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg) is the first listed.
NCT05733455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05733455 about?
NCT05733455 is a clinical study titled "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 (...
What is the current status of trial NCT05733455?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2023-05-09. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT05733455?
The interventions under investigation include: Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg) (DRUG), Placebo (microcrystalline cellulose), 2 capsules (DRUG), FreeStyle Libre Pro (DEVICE), Oral glucose tolerance test (OGTT) with Trutol glucose beverage (DIAGNOSTIC_TEST), BOOST Plus nutritional beverage (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05733455?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05733455's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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