A Study of LY4065967 in Healthy Participants

Официальное название

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

Обзор

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.

Вмешательства

• Препарат LY4065967 Tablet
  Administered orally
• Препарат LY4065967 Formulated Capsule
  Administered orally
• Препарат LY4065967 Capsule
  Administered orally

Первичные конечные точки

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

Вторичные конечные точки (1)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 2 центра

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

Идентификаторы

NCT: NCT07607483 · 27902 · J4X-MC-LWCC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗