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OpenTrials
Completed

NCT Number: NCT07339735

A Study of LY4064809 in Healthy Adult Participants

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704-2526, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4064809 Test Formulation

Drug

Administered orally

Other names: STX-478

LY4064809 Reference Formulation

Drug

Administered orally

Other names: STX-478

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809

    Time frame: Predose on Day 1 Through Day 28

    PK: Cmax of LY4064809

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

    Time frame: Predose on Day 1 Through Day 28

    PK: AUC of LY4064809

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Assess the Relative Bioavailability of Two LY4064809 Formulations in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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