Healthy Participants
Conditions
Keywords
Glucagon-like peptide receptor agonist (GLP-1RA), Type 2 Diabetes Mellitus (T2DM), Glucose Metabolism Disorders, Metabolic Diseases, Obesity management, Pharmacokinetics, Relative bioavailability, Obesity and Related Co-morbidities
Brief 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.
Detailed 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 treatment periods in each cohort - Period 1, and Period 2 during which participants will be admitted to the Clinical Unit and receive a single oral dose of elecoglipron in each period. * A final Follow-up Visit.
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.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed drug concentration (Cmax) | At pre-defined intervals from Day 1 to Day 15 | 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) | At pre-defined intervals from Day 1 to Day 15 | 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) | At pre-defined intervals from Day 1 to Day 15 | To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. |
| Time to reach maximum observed concentration (tmax) | At pre-defined intervals from Day 1 to Day 15 | To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. |
| Terminal elimination rate constant (λz) | At pre-defined intervals from Day 1 to Day 15 | To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. |
| Terminal elimination half-life (t1/2λz) | At pre-defined intervals from Day 1 to Day 15 | To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. |
| Apparent total body clearance (CL/F) | At pre-defined intervals from Day 1 to Day 15 | To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. |
| Apparent volume of distribution based on the terminal phase (Vz/F) | At pre-defined intervals from Day 1 to Day 15 | To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. |
| Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf) | At pre-defined intervals from Day 1 to Day 15 | To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. |
| Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast) | At pre-defined intervals from Day 1 to Day 15 | To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. |
| Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax) | At pre-defined intervals from Day 1 to Day 15 | To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | From screening (Day -28) up to follow-up visit (Day 18-Day 22) | To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants. |
Countries
United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed