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

Phase 1RecruitingNCT07723833

AstraZeneca152 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

152

Conditions

Healthy Participants

Interventions

Elecoglipron Reference Formulation Dose ADRUG

Elecoglipron tablets will be administered orally.

Elecoglipron Test formulation 1 Dose ADRUG

Elecoglipron tablets will be administered orally.

Elecoglipron Reference Formulation Dose BDRUG

Elecoglipron tablets will be administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (2)

Research Site

Glendale, California, United States

RECRUITING

Research Site

Brooklyn, Maryland, United States

RECRUITING