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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]-STX-478

• Registration Number: NCT06901336
• Lead Sponsor: Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-20
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-28
• Status Verified: 2025-05
• Primary Completion: 2025-05-06
• Study Completion: 2025-05-06
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of the Total Radioactive Dose in Urinary, Fecal, and Urinary and Fecal Combined Excretion	Baseline, Up to Day 29

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pharmaron Clinical Pharmacology Center Inc; 🇺🇸 Baltimore, Maryland, United States