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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAstraZeneca

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

Qualifiers

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

Treatments tested in this trial

  • Elecoglipron Reference Formulation Dose A
  • Elecoglipron Test formulation 1 Dose A
  • Elecoglipron Reference Formulation Dose B
  • Elecoglipron Test formulation 1 Dose B
  • Elecoglipron Test formulation 2 Dose A
  • Elecoglipron Test formulation 2 Dose B

Treatment groups

152 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators