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A Study of Elecoglipron Formulations in Healthy Participants

This study is looking at how your body processes different oral forms of a drug called elecoglipron. Researchers want to understand how much of the drug gets into your bloodstream and how quickly, comparing a reference formulation to two new test formulations. This helps them find the best way to deliver elecoglipron. You can join if you are a healthy adult between 18 and 55 years old. For the study to be considered successful, researchers will measure the maximum amount of elecoglipron in your blood (Cmax) and how long it stays in your system (AUClast and AUCinf) over 15 days after you take the drug. The current status of this study is unclear.

Study design
This is a Phase 1, open-label (meaning you and the study staff will know which treatment you receive), randomized study involving 152 healthy participants.
What's involved
You will have a screening visit, two treatment periods where you stay at a clinical unit and receive a single oral dose of elecoglipron, and a final follow-up visit.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up after treatment, with drug levels measured for up to 15 days after each dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07723833

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
AstraZeneca
~152 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Elecoglipron Reference Formulation Dose AElecoglipron Test formulation 1 Dose AElecoglipron Reference Formulation Dose BElecoglipron Test formulation 1 Dose BElecoglipron Test formulation 2 Dose AElecoglipron Test formulation 2 Dose B

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum observed drug concentration (Cmax)
Measured over At pre-defined intervals from Day 1 to Day 15
+10 more outcomes measured

Conditions

Healthy Participants

Explore related trials

Healthy Participants

Where it's being run

2 sites across 2 states
California1
Maryland1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Maximum observed drug concentration (Cmax)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Area under concentration-time curve from time 0 to infinity (AUCinf)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Time to reach maximum observed concentration (tmax)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Terminal elimination rate constant (λz)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Terminal elimination half-life (t1/2λz)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Apparent total body clearance (CL/F)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Apparent volume of distribution based on the terminal phase (Vz/F)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

  • Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)At pre-defined intervals from Day 1 to Day 15

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.