A Study of LY4064809 [14C]-STX-478 in Healthy Male Participants

NCT06901336 | Completed Phase 1 FDA Drug

• 3 other identifiers: 27692J6M-MC-JSGBSTX-478-102
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of the Total Radioactive Dose in Urinary, Fecal, and Urinary and Fecal Combined Excretion

  Baseline, Up to Day 29

Secondary Outcomes (4)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of 14C and STX-478

  Predose up to Day 29 Post Dose

• PK: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC 0- inf) of 14C and STX-478

  Predose up to Day 29 Post Dose

• Total Radioactivity Recovered in Urine and Feces

  Predose up to Day 29 Post Dose

• Total Number of Metabolites and Identification of Metabolites of STX-478 in Plasma, Urine, and Feces

  Predose up to Day 29 Post Dose

Study Arms (1)

[14C]-STX-478

EXPERIMENTAL

Healthy participants will receive a single dose of \[14C\]-STX-478.

Drug: [14C]-STX-478

Interventions

[14C]-STX-478 DRUG

oral administration

Also known as: LY4064809

[14C]-STX-478

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Participants with female sexual partner(s) of reproductive potential may be enrolled if the male: * is documented to be surgically sterile (i.e., successfully vasectomized) at least 90 days prior to screening; or * agrees to use effective contraception, for at least 90 days after receiving study drug and agrees to refrain from sperm donation from the time of Screening through 90 days post dose.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight
• ≥ 55.0 kg and ≤ 100.0 kg at Screening.
• Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) and human immunodeficiency virus antibody and antigen (HIV Ab/Ag).
• Non-smoker (with no use of other tobacco or nicotine containing products, in any form), as documented by history (no nicotine within 6 months prior to Screening) and a negative cotinine test at Screening and admission

You may not qualify if:

• History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
• Any history of serious allergic/hypersensitivity reactions
• History or presence of alcohol or drug abuse (self-reported) within 2 years prior to Screening.
• Administration of any prescription or non-prescription drugs (including antacids; however, acetaminophen at a dose ≤ 1 g/day is permitted), herbal remedies or vitamin supplements from 28 days, or five half-lives, whichever is longer, prior to Admission.

Sponsors & Collaborators

• Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company: lead

Study Sites (1)

Pharmaron Clinical Pharmacology Center Inc

Baltimore, Maryland, 42374, United States

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 28, 2025
• Study Start: March 20, 2025
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)