Elecoglipron in healthy people: comparing different oral forms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label, randomized, 2-period crossover study will evaluate up to three elecoglipron oral formulations (one reference and two test formulations) at two dose levels across four independent cohorts. In each cohort, participants receive two single doses in two treatment periods with a randomized Test-Reference or Reference-Test sequence, separated by a washout period. The trial collects pharmacokinetic data to understand how the body processes each formulation and dose. Safe administration occurs in a Clinical Unit with standard monitoring, followed by a follow-up visit.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Glendale, California, United States Recruiting
• Research Site
  Brooklyn, Maryland, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.