DRUG
Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally.
A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
Status
Not yet recruiting
Phase
Phase 1
Enrollment
152
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Jul 23, 2026
Study start
Jul 27, 2026
Primary completion
Nov 18, 2026
Study completion
Nov 18, 2026
Results posted
Not reported
Registry updated
Jul 23, 2026
Outcomes
What the study measures.
Primary outcomes
Maximum observed drug concentration (Cmax)
Time frame · 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)
Time frame · 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)
Time frame · 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)
Time frame · 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)
Time frame · 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)
Time frame · 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)
Time frame · 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)
Time frame · 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 outcomes
Number of participants with adverse events (AEs)
Time frame · 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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- ALL
- 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.
Study locations
2 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Glendale, California, United States
Research Site
Brooklyn, Maryland, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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