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Alpelisib for Healthy Volunteers

Phase 1
Waitlist Available
Led By Joshua R Cook, MD, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 4 (up to 180 minutes from the start of the procedure)
Awards & highlights

Study Summary

This trial will test a drug to see how it affects how the body handles fat & sugar in healthy people. Participants will take a dose of a drug or placebo, then have tests to compare results.

Who is the study for?
Healthy adults aged 18-65 with a BMI of 18.0-26.9 kg/m2 can join this trial. They must not be pregnant, breastfeeding, or have any chronic diseases and should not be on prescription meds except vitamins. Participants need to use effective contraception if applicable and agree to fast for the study.Check my eligibility
What is being tested?
The trial tests how a single dose of Alpelisib affects glucose and lipid metabolism in healthy people by inducing temporary insulin resistance. It involves taking Alpelisib or placebo, fasting, wearing a glucose monitor for three days, and undergoing an oral glucose tolerance test.See study design
What are the potential side effects?
Possible side effects include changes in blood sugar levels which will be monitored closely with continuous glucose monitoring devices and through blood tests during the oral glucose tolerance test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4 (up to 180 minutes from the start of the procedure)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4 (up to 180 minutes from the start of the procedure) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fasting plasma glucose
Fasting serum C-peptide
Fasting serum insulin
Secondary outcome measures
Fasting serum high-density lipoprotein (HDL) cholesterol levels
Fasting serum low-density lipoprotein (LDL) cholesterol levels
Fasting serum or plasma apolipoprotein B levels
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Alpelisib treatmentExperimental Treatment4 Interventions
Participants will ingest a single dose of alpelisib 300 mg (two overencapsulated 150-mg tablets)
Group II: Placebo treatmentPlacebo Group4 Interventions
Participants will ingest a single dose of placebo (two capsules filled with microcrystalline cellulose)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral glucose tolerance test (OGTT) with Trutol glucose beverage
2023
Completed Phase 1
~30
FreeStyle Libre Pro
2023
Completed Phase 1
~30
Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg)
2023
Completed Phase 1
~30
BOOST Plus nutritional beverage
2023
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,808 Total Patients Enrolled
10 Trials studying Insulin Resistance
460 Patients Enrolled for Insulin Resistance
Joshua R Cook, MD, PhDPrincipal InvestigatorColumbia University
5 Previous Clinical Trials
162 Total Patients Enrolled
5 Trials studying Insulin Resistance
162 Patients Enrolled for Insulin Resistance

Media Library

Alpelisib treatment Clinical Trial Eligibility Overview. Trial Name: NCT05733455 — Phase 1
Insulin Resistance Research Study Groups: Placebo treatment, Alpelisib treatment
Insulin Resistance Clinical Trial 2023: Alpelisib treatment Highlights & Side Effects. Trial Name: NCT05733455 — Phase 1
Alpelisib treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05733455 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers accepting new participants for this clinical trial at present?

"Data on clinicaltrials.gov shows that this investigation is currently recruiting volunteers, having first been posted on the 1st of March 2023 and last updated a month later."

Answered by AI

Does this trial offer participation to seniors?

"According to the inclusion criteria, only individuals aged 18-65 are eligible for this trial. However, there are other studies available for those younger than 18 (51 trials) and seniors over 65 years old (325 trials)."

Answered by AI

Could you assess the potential risks associated with Alpelisib therapy?

"As this trial is currently in its first experimental phase, the safety of Alpelisib can only be estimated at a score of 1 due to limited data supporting both efficacy and security."

Answered by AI

Is my eligibility suitable for participation in this research project?

"This clinical trial, which is accepting a maximum of 12 participants, requires applicants to have insulin resistance and be between the ages 18 and 65."

Answered by AI

What key goals is this research project attempting to achieve?

"This clinical trial focuses on assessing fasting serum insulin levels over a 10-hour period. The secondary objectives of this study include measuring plasma glucose levels, the area under the curve (AUC) during OGTT, and serum insulin levels during OGTT in alpelisib versus placebo patients."

Answered by AI

How many participants are under observation for this experiment?

"Yes, according to the material posted on clinicaltrials.gov , this research is actively searching for volunteers. This study was originally uploaded on March 1st of 2023 and had its most recent update on February 3rd of that same year. It requires 12 participants from one medical facility."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of Alpelisib in Healthy Volunteers
Joshua Cook 2023. "Effect of Alpelisib in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05733455.
~12 spots leftby Apr 2025
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