A Study of LY4065967 in Healthy Participants

Official title

A Phase 1, Randomized, Open-Label, Crossover Study to Investigate the Relative Bioavailability of LY4065967 Formulations in Healthy Participants

Overview

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.

Interventions

• Drug LY4065967 Tablet
  Administered orally
• Drug LY4065967 Formulated Capsule
  Administered orally
• Drug LY4065967 Capsule
  Administered orally

Primary outcome measures

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967 [Time frame: Baseline Up to Day 17]
• PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t [AUC(0- tlast)] [Time frame: Baseline Up to Day 17]
• PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity [AUC(0-∞)] [Time frame: Baseline Up to Day 17]

Secondary outcome measures (1)

• PK: Time of Maximum Observed Drug Concentration (tmax) [Time frame: Baseline Up to Day 17]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 2 centers

• Fortrea Clinical Research Unit — Daytona Beach
• Fortrea Clinical Research Unit — Dallas

Identifiers

NCT: NCT07607483 · 27902 · J4X-MC-LWCC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗