About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
Elecoglipron Reference Formulation Dose A
DrugElecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose A
DrugElecoglipron tablets will be administered orally.
Elecoglipron Reference Formulation Dose B
DrugElecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose B
DrugElecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose A
DrugElecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose B
DrugElecoglipron tablets will be administered orally.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Maximum observed drug concentration (Cmax)
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)
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)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time to reach maximum observed concentration (tmax)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Secondary outcomes
Number of participants with adverse events (AEs)
To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants.
Sponsors and contacts
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