A Study of LY4064809 [14C]-STX-478 in Healthy Male Partic... | NCT06901336

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

NCT06901336

Sponsor

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

Status

Completed

Last Update Posted

May 25, 2025Actual

Enrollment

8Actual

Phase

Phase 1

Conditions

Healthy

Interventions

[14C]-STX-478

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
J6M-MC-JSGB	Other Identifier	Eli Lilly and Company
STX-478-102	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2025Actual

Primary Completion Date

May 6, 2025Actual

Completion Date

May 6, 2025Actual

First Submitted Date

Mar 24, 2025

First Submission Date that Met QC Criteria

Mar 24, 2025

First Posted Date

Mar 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2025

Last Update Posted Date

May 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Label	Type	Description	Intervention Names
[14C]-STX-478	Experimental	Healthy participants will receive a single dose of [14C]-STX-478.	Drug: [14C]-STX-478

Name	Type	Description	Arm Group Labels	Other Names
[14C]-STX-478	Drug	oral administration	[14C]-STX-478	LY4064809

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of the Total Radioactive Dose in Urinary, Fecal, and Urinary and Fecal Combined Excretion		Baseline, Up to Day 29

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

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.

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided