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Completed

NCT Number: NCT06901336

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron Clinical Pharmacology Center Inc

Baltimore, Maryland, 42374, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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.

Treatment and study plan

[14C]-STX-478

Drug

oral administration

Other names: LY4064809

Primary outcomes

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

    Time frame: Baseline, Up to Day 29

Secondary outcomes

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

    Time frame: Predose up to Day 29 Post Dose

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

    Time frame: Predose up to Day 29 Post Dose

  3. Total Radioactivity Recovered in Urine and Feces

    Time frame: Predose up to Day 29 Post Dose

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

    Time frame: Predose up to Day 29 Post Dose

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-STX-478 Following Single-Dose Oral Administration

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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