NCT07339735

Brief Summary

The purpose of this study is to find out how much LY4064809 gets into the blood stream and how long it takes the body to get rid of it when it is given as two formulations. For each participant, the study will last about nine weeks. Participants will remain in the clinical research center for about one month.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

January 6, 2026

Last Update Submit

April 17, 2026

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809

    PK: Cmax of LY4064809

    Predose on Day 1 Through Day 28

  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809

    PK: AUC of LY4064809

    Predose on Day 1 Through Day 28

Study Arms (2)

LY4064809 Test

EXPERIMENTAL

LY4064809 test (Phase 3 formulation) formulation administered orally in one of two periods.

Drug: LY4064809 Test FormulationDrug: LY4064809 Reference Formulation

LY4064809 Reference

EXPERIMENTAL

LY4064809 reference (Phase 1 formulation) formulation administered orally in one of two periods.

Drug: LY4064809 Test FormulationDrug: LY4064809 Reference Formulation

Interventions

LY4064809 Test FormulationDRUG

Administered orally

Also known as: STX-478
LY4064809 ReferenceLY4064809 Test
LY4064809 Reference FormulationDRUG

Administered orally

Also known as: STX-478
LY4064809 ReferenceLY4064809 Test

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Are healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission.
  • Have clinical laboratory test results within the normal range
  • Have normal blood pressure and pulse rate or not clinically significant
  • Have a BMI within the range 18 to 32 kg/m2
  • Participants assigned male at birth or assigned female at birth who are not of childbearing potential

You may not qualify if:

  • History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee):
  • metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome
  • bile duct disease, including removal of the gall bladder
  • digestive system disease
  • blood disease
  • disease of the nervous system
  • significant history of, or presence of, liver disease, including any abnormal liver function tests
  • heart disease
  • Have an abnormal electrocardiogram (ECG) at screening or admission
  • History of a major surgical procedure within 30 days prior to screening
  • Diagnosed or treated cancer within 5 years prior to screening, with the exception of the following cancers cured through treatment: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and in situ carcinoma of the cervix cured through surgery
  • Clinically significant history of multiple or severe drug hypersensitivity reactions or drug allergies, as determined by the investigator
  • Have used or plan to use medication within 14 days prior to admission, or plan to use during the study with the exception of acetaminophen
  • Have creatinine lab clearance less than 90mL/min calculated using the Cockroft-Gault equation at screening
  • Have a positive Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody or human immunodeficiency virus 1 and 2 antibody results at the screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704-2526, United States

Location

MeSH Terms

Interventions

STX-478

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 14, 2026

Study Start

January 12, 2026

Primary Completion

March 19, 2026

Study Completion

March 19, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)