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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests different forms of elecoglipron taken by mouth in healthy people. It looks at how the body processes the drug and how safe it is.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must be healthy and have veins suitable for repeated blood draws or a small tube used to access a vein.
  • All women must have negative pregnancy tests at screening and when entering the study unit.
  • Women who can become pregnant must not be breastfeeding. If sexually active with men, they must use an approved, highly effective birth control method.
  • Women who cannot become pregnant must have confirmed menopause or records of surgery that permanently prevents pregnancy.
  • Men who can father a child and are sexually active with partners who can become pregnant must follow the study’s birth control rules.
  • Must have a body mass index (BMI, a measure based on height and weight) from 18.5 to 30 and weigh at least 50 kg (about 110 pounds).

Who can't join

  • A history of a major disease or health disorder.
  • A history of acute pancreatitis, or sudden swelling of the pancreas.
  • A digestive problem or other condition that affects how the body takes in, moves, breaks down, or removes drugs.
  • Significant inflammatory bowel disease (swelling in the intestines), slow stomach emptying, or severe disease or surgery affecting the upper digestive tract.
  • Any major illness, medical or surgical procedure, or injury.
  • Taking elecoglipron within the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

CA

MD