A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

Официальное название

A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

Обзор

The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.

Подробное описание

This is a phase I, open-label, randomized, 2-period crossover study with 4-cohorts. All 4 cohorts are independent and non-sequential parts in this study. Each cohort will evaluate 2 formulations (test formulation and reference formulation) of elecoglipron across 2 study treatment periods. Participants within each cohort will be randomized to one of 2 treatment sequences (Test-Reference or Reference-Test).

In total 3 formulations will be evaluated at 2 dose levels each:

* Reference formulation * Test formulation 1 * Test formulation 2

The study will comprise:

* A Screening Period. * 2 treatment periods in each cohort - Period 1, and Period 2 during which participants will be admitted to the Clinical Unit and receive a single oral dose of elecoglipron in each period. * A final Follow-up Visit.

Вмешательства

• Препарат Elecoglipron Reference Formulation Dose A
  Elecoglipron tablets will be administered orally.
• Препарат Elecoglipron Test formulation 1 Dose A
  Elecoglipron tablets will be administered orally.
• Препарат Elecoglipron Reference Formulation Dose B
  Elecoglipron tablets will be administered orally.
• Препарат Elecoglipron Test formulation 1 Dose B
  Elecoglipron tablets will be administered orally.
• Препарат Elecoglipron Test formulation 2 Dose A
  Elecoglipron tablets will be administered orally.
• Препарат Elecoglipron Test formulation 2 Dose B
  Elecoglipron tablets will be administered orally.

Первичные конечные точки

• Maximum observed drug concentration (Cmax) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]
• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]
• Area under concentration-time curve from time 0 to infinity (AUCinf) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]
• Time to reach maximum observed concentration (tmax) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]
• Terminal elimination rate constant (λz) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]
• Terminal elimination half-life (t1/2λz) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]
• Apparent total body clearance (CL/F) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]
• Apparent volume of distribution based on the terminal phase (Vz/F) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]
• Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]
• Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast) [Срок оценки: At pre-defined intervals from Day 1 to Day 15]

Вторичные конечные точки (1)

• Number of participants with adverse events (AEs) [Срок оценки: From screening (Day -28) up to follow-up visit (Day 18-Day 22)]

Критерии участия

Критерии включения

• Healthy participants with suitable veins for cannulation or repeated venipuncture.
• All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
• Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.
• Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.
• Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg.

Критерии исключения

• History of any clinically important disease or disorder.
• History of acute pancreatitis.
• History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
• Any clinically important illness, medical/surgical procedure, or trauma.
• Participants who have previously received elecoglipron within the last 3 months.

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

Лечение

Центры проведения

США · 2 центра

• Research Site — Glendale
• Research Site — Brooklyn

Идентификаторы

NCT: NCT07723833 · D7260C00023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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