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

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.

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Key information

Conditions

Healthy Participants Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Glendale, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.