LY4064809 for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how the new drug, LY4064809, moves through the body and how long it takes to clear. Researchers are testing two different formulations, and each participant will try both at different times. The trial seeks healthy individuals without significant medical conditions, such as heart or liver disease, and who are not on medications. Participants will need to stay at the research center for about a month. This trial is crucial for understanding the drug's absorption and clearance in the body. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking your current medications at least 14 days before joining the study, except for acetaminophen.
Is there any evidence suggesting that LY4064809 is likely to be safe for humans?
Research has shown that LY4064809 has undergone safety testing in several studies. One study tested it with esomeprazole, a common heartburn medicine, to determine if food affects its safety. The results indicated that participants generally tolerated LY4064809 well. Another study examined how the drug moves through the body, and no serious side effects were reported. These findings suggest that LY4064809 does not cause major problems in healthy adults. However, as this is a Phase 1 trial, the main goal is to understand how the drug behaves in the body, and safety information is still being collected. Participants can feel reassured that early results have been positive so far.12345
Why are researchers excited about this trial's treatments?
LY4064809 is unique because it is being tested in two different formulations, one from Phase 1 and the other from Phase 3, to see how they perform in healthy adults. This treatment is administered orally, which could offer a more convenient option compared to other forms that might require injections or more invasive delivery methods. Researchers are excited about LY4064809 because its development through different phases suggests it has shown potential benefits and safety so far, and this trial could provide further insights into its effectiveness and optimal formulation for future use.
What evidence suggests that this trial's treatments could be effective?
Research shows that LY4064809 has potential to improve cancer treatments. The current study examines how LY4064809 is processed in the body. Participants in this trial will receive either the LY4064809 reference formulation or the LY4064809 test formulation. Previous studies combined LY4064809 with other cancer treatments, suggesting it might enhance their effectiveness. Although solid proof of its direct impact on specific conditions is lacking, its use in combination therapies appears promising.45678
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for healthy adults with normal blood pressure, pulse rate, and clinical lab results. Participants must have a BMI of 18-32 kg/m2 and not be able to bear children. They should pass a medical evaluation including history, physical exam, vital signs, and ECG.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LY4064809 in two formulations to assess bioavailability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4064809
Trial Overview
The study tests how much of the drug LY4064809 enters the bloodstream and its elimination time using two different formulations. Each participant will be involved in the study for about nine weeks with a one-month stay at the research center.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
LY4064809 test (Phase 3 formulation) formulation administered orally in one of two periods.
LY4064809 reference (Phase 1 formulation) formulation administered orally in one of two periods.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
A Study of LY4064809 [14C]-STX-478 in Healthy Male ...
Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...
LY4064809 + Esomeprazole for Healthy Adults
Research has shown that LY4064809 is under study to determine if it can enhance the effectiveness of other cancer treatments. Earlier studies used LY4064809 ...
A Study of LY4064809 in Healthy Adult Chinese Participants
Are overtly healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening ...
LY4064809 for Healthy Adults · Info for Participants
The purpose of this study is to find out how much LY4064809 gets into the blood stream and how long it takes the body to get rid of it when it is given as ...
5.
investor.lilly.com
investor.lilly.com/news-releases/news-release-details/lilly-highlight-progress-across-key-programs-early-and-advancedLilly to highlight progress across key programs in early and ...
In a poster presentation, Lilly will share findings from PIKALO-1, the ongoing Phase 1/2 study evaluating LY4064809 alone and in combination with endocrine ...
A Study of LY4064809 in Healthy Adult Participants
It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo ...
NCT06991179 | A Study of Food Effect and Esomeprazole ...
The purpose of this study is to evaluate the safety and effect of food on LY4064809 and the safety and effect of stomach changes by a proton pump inhibitor (PPI) ...
8.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-food-effect-and-esomeprazole-on-ly4064809-in-healthy-adult-participantsA Study of Food Effect and Esomeprazole on LY4064809 in ...
The purpose of this study is to evaluate the safety and effect of food on LY4064809 and the safety and effect of stomach changes by a proton ...
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