A Study of LY4064809 in Healthy Adult Participants

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: LY4064809 Test Formulation; Drug: LY4064809 Reference Formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07339735

J6M-MC-JSGG (Other Identifier)

27796

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

LY4064809 Test

Experimental group

Description:

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

Treatment:

Drug: LY4064809 Reference Formulation

Drug: LY4064809 Test Formulation

LY4064809 Reference

Experimental group

Description:

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

Treatment:

Drug: LY4064809 Reference Formulation

Drug: LY4064809 Test Formulation