8 Participants Needed

STX-478 for Healthy Subjects

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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Age: 18 - 65
Sex: Male
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to conduct blood tests to measure how much STX-478 is in the bloodstream and how the body handles and eliminates it in healthy participants. This study will involve a single dose of 14C radiolabeled STX-478. This means that a radioactive tracer substance, C14, will be incorporated into the study drug STX-478 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of STX-478.

Who Is on the Research Team?

C1

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

My BMI is between 18.0 and 32.0.
I have tested negative for hepatitis B, C, and HIV.
My weight is between 55 and 100 kg.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of 14C radiolabeled STX-478 to study absorption, distribution, metabolism, and excretion

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and tolerability, and to measure how the body handles and eliminates STX-478

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • [14C]-STX-478
Trial Overview [14C]-STX-478 is being tested to see how it's processed in the body after a single dose with a radioactive tracer called C14. The study will track how much of the drug and its byproducts end up in blood, urine, feces, and expired air.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: [14C]-STX-478Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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

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