STX-478 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the body processes and eliminates a new drug called STX-478 in healthy individuals. Researchers will track the drug's movement through the bloodstream and its exit from the body using a small amount of a radioactive tracer. The study will also assess the drug's safety and tolerability for participants. Ideal candidates are healthy non-smokers with a body mass index (BMI) between 18 and 32, who have not used nicotine for at least six months. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription or non-prescription drugs, herbal remedies, or vitamin supplements at least 28 days before joining the trial, except for acetaminophen at a dose of 1 gram per day or less.
Is there any evidence suggesting that STX-478 is likely to be safe for humans?
Research has shown that STX-478 is generally safe. Previous studies found that most side effects were mild to moderate, indicating they weren't too serious. Importantly, no participants discontinued the treatment due to these side effects. Additionally, STX-478 appears to cause fewer metabolic problems compared to similar treatments, suggesting it might be easier for the body to handle. Overall, early findings suggest that STX-478 is well-tolerated.12345
Why do researchers think this study treatment might be promising?
STX-478 is unique because it incorporates a radiolabeled component, [14C], which allows researchers to track how the drug is absorbed, distributed, metabolized, and excreted in the body. Unlike standard treatments that primarily focus on symptomatic relief or targeting a specific pathway, STX-478 offers insights into the drug's behavior in the body, potentially leading to more targeted and efficient treatments. Researchers are excited about this because understanding the pharmacokinetics of STX-478 could pave the way for developing novel therapies with optimized dosing and reduced side effects.
What evidence suggests that STX-478 is safe and tolerable in healthy subjects?
Research has shown that STX-478, a new cancer treatment, holds promise for certain cancers. Early studies indicate it targets specific cellular changes that lead to solid tumors. These changes occur in a part of the cell often linked to cancer growth. Initial clinical results suggest that STX-478 is effective against various solid tumors when used alone. This targeted approach may reduce side effects compared to older treatments.45678
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 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 male participants with a BMI between 18.0 and 32.0 kg/m2, weighing between 55.0 and 100.0 kg, who are non-smokers (including no nicotine use within the last six months). They must test negative for hepatitis B, C, and HIV.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of 14C radiolabeled STX-478 to study absorption, distribution, metabolism, and excretion
Follow-up
Participants are monitored for safety and tolerability, and to measure how the body handles and eliminates STX-478
What Are the Treatments Tested in This Trial?
Interventions
- [14C]-STX-478
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
Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
Lead Sponsor