A Study of LY4064809 in Healthy Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY4064809 Test

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

Group Type EXPERIMENTAL

LY4064809 Test Formulation

Intervention Type DRUG

Administered orally

LY4064809 Reference Formulation

Intervention Type DRUG

Administered orally

LY4064809 Reference

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

Group Type EXPERIMENTAL

LY4064809 Test Formulation

Intervention Type DRUG

Administered orally

LY4064809 Reference Formulation

Intervention Type DRUG

Administered orally

Interventions

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LY4064809 Test Formulation

Administered orally

Intervention Type DRUG

LY4064809 Reference Formulation

Administered orally

Intervention Type DRUG

Other Intervention Names

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STX-478 STX-478

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes