RecruitingPhase 1NCT07723833

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

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


Sponsor

AstraZeneca

Enrollment

152 participants

Start Date

Jul 27, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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.

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Interventions

DRUGElecoglipron Reference Formulation Dose A

Elecoglipron tablets will be administered orally.

DRUGElecoglipron Test formulation 1 Dose A

Elecoglipron tablets will be administered orally.

DRUGElecoglipron Reference Formulation Dose B

Elecoglipron tablets will be administered orally.

DRUGElecoglipron Test formulation 1 Dose B

Elecoglipron tablets will be administered orally.

DRUGElecoglipron Test formulation 2 Dose A

Elecoglipron tablets will be administered orally.

DRUGElecoglipron Test formulation 2 Dose B

Elecoglipron tablets will be administered orally.


Locations(2)

Research Site

Glendale, California, United States

Research Site

Brooklyn, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT07723833


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