A Study of LY4065967 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY4065967 Formulated Capsule; Drug: LY4065967 Capsule; Drug: LY4065967 Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT07607483

J4X-MC-LWCC (Other Identifier)

27902

Details and patient eligibility

About

The main purpose of this study is to compare 3 different forms of LY4065967 - a tablet and 2 types of capsule - to see how much and how quickly each gets into the bloodstream after it is swallowed, and to check for any side effects. For each participant, the study will last about 7 weeks and will include 3 stays in the Clinical Research Unit (CRU). Each stay will last 3 nights.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
• Have clinical laboratory test results within normal reference range for the population or investigative site.
• Have an electrocardiogram (ECG) at screening considered to be within acceptable limits by the investigator.
• Have a body mass index within the range 18.0 to 35.0 kilograms per square meter (kg/m²) (inclusive).
• Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB) may participate in this trial.
• Have venous access sufficient to allow for blood sampling.

Exclusion criteria

• Have a history of or current clinically significant medical conditions, including cardiovascular disease, electrolyte abnormalities, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders that, in the judgment of the investigator, could predispose to arrhythmia, pose a risk with study participation, significantly alter the absorption, metabolism, or elimination of the study drug, or interfere with the interpretation of study data.
• Have systolic blood pressure of 140 millimeters of mercury (mmHg) or greater and diastolic blood pressure of 90 mmHg or greater at screening.
• Have a history of clinically significant known allergies to LY4065967, related compounds, or any components of the formulation, or history of significant atopy.
• Have a history of alcohol, opioids, stimulants or hallucinogens use disorder within 2 years prior to screening or a current use disorder by Diagnostic and Statistical Manual of Mental Disorders (APA 2013).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

LY4065967 (Reference)

Experimental group

Description:

Administered orally as a capsule in one of three treatment periods.

Treatment:

Drug: LY4065967 Capsule

LY4065967 (Test 1)

Experimental group

Description:

Administered orally as a tablet in one of three treatment periods.

Treatment:

Drug: LY4065967 Tablet

LY4065967 (Test 2)

Experimental group

Description:

Administered orally as a formulated capsule in one of three treatment periods.

Treatment:

Drug: LY4065967 Formulated Capsule