A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elecoglipron Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A, Elecoglipron Reference Formulation Dose B, Elecoglipron Test formulation 1 Dose B.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally. - Drug Elecoglipron Test formulation 1 Dose A
Elecoglipron tablets will be administered orally. - Drug Elecoglipron Reference Formulation Dose B
Elecoglipron tablets will be administered orally. - Drug Elecoglipron Test formulation 1 Dose B
Elecoglipron tablets will be administered orally. - Drug Elecoglipron Test formulation 2 Dose A
Elecoglipron tablets will be administered orally. - Drug Elecoglipron Test formulation 2 Dose B
Elecoglipron tablets will be administered orally.
Primary outcome measures
- Maximum observed drug concentration (Cmax) [Time frame: At pre-defined intervals from Day 1 to Day 15]
- Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) [Time frame: At pre-defined intervals from Day 1 to Day 15]
- Area under concentration-time curve from time 0 to infinity (AUCinf) [Time frame: At pre-defined intervals from Day 1 to Day 15]
- Time to reach maximum observed concentration (tmax) [Time frame: At pre-defined intervals from Day 1 to Day 15]
- Terminal elimination rate constant (λz) [Time frame: At pre-defined intervals from Day 1 to Day 15]
- Terminal elimination half-life (t1/2λz) [Time frame: At pre-defined intervals from Day 1 to Day 15]
- Apparent total body clearance (CL/F) [Time frame: At pre-defined intervals from Day 1 to Day 15]
- Apparent volume of distribution based on the terminal phase (Vz/F) [Time frame: At pre-defined intervals from Day 1 to Day 15]
- Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf) [Time frame: At pre-defined intervals from Day 1 to Day 15]
- Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast) [Time frame: At pre-defined intervals from Day 1 to Day 15]
Secondary outcome measures (1)
- Number of participants with adverse events (AEs) [Time frame: From screening (Day -28) up to follow-up visit (Day 18-Day 22)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Research Site — Glendale
- Research Site — Brooklyn
Identifiers
NCT: NCT07723833 · D7260C00023