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NCT07723833PHASE1RecruitingAccepts Healthy Volunteers

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

AstraZeneca

Start Date

7/27/2026

Completion Date

11/18/2026

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to 55 years

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.

Interventions

DRUG

Elecoglipron Reference Formulation Dose A

DRUG

Elecoglipron Test formulation 1 Dose A

DRUG

Elecoglipron Reference Formulation Dose B

DRUG

Elecoglipron Test formulation 1 Dose B

DRUG

Elecoglipron Test formulation 2 Dose A

DRUG

Elecoglipron Test formulation 2 Dose B

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Conditions

Healthy Participants

Locations

Research Site

Glendale, California 91206

United States

Research Site

Brooklyn, Maryland 21225

United States