A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
About this study
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.
- Condition
- Healthy Participants
- Tested
- Elecoglipron Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A, Elecoglipron Reference Formulation Do...
- Sponsor
- AstraZeneca
Who can join
- Age
- 18 to 55 years
- Sex
- All sexes
- Healthy volunteers
- Accepted
Inclusion 9
- Minimum age: 18 years
- Maximum age: 55 years
- Study condition: Healthy Participants
- 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 6
- 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.
Where
2 sites, 2 recruiting
Research Site
Brooklyn, Maryland, United States
Research Site
Glendale, California, United States
Contact
-
AstraZeneca Clinical Study Information Center
1-877-240-9479 information.center@astrazeneca.com
Potential match only. Final eligibility is determined by the study team.