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

NCT07723833

Not Yet RecruitingPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

Interventions: Elecoglipron Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A, Elecoglipron Reference Formulation Dose B, Elecoglipron Test formulation 1 Dose B, Elecoglipron Test formulation 2 Dose A

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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)

Glendale, California, United States
Brooklyn, Maryland, United States