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
AstraZeneca
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.
Description
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 treat…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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 chil…
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 SiteGlendale, California
- Research SiteBrooklyn, Maryland