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

NCT ID: NCT06901336

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2025-05-06

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[14C]-STX-478

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

Group Type: EXPERIMENTAL

[14C]-STX-478

Intervention Type: DRUG

oral administration

Interventions

[14C]-STX-478

oral administration

Intervention Type: DRUG

Other Intervention Names

LY4064809

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Pharmaron Clinical Pharmacology Center Inc

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

J6M-MC-JSGB

Identifier Type: OTHER

Identifier Source: secondary_id

STX-478-102

Identifier Type: OTHER

Identifier Source: secondary_id

27692

Identifier Type: -

Identifier Source: org_study_id