A Phase 1 interventional study of Elecoglipron Reference Formulation Dose A and Elecoglipron Test formulation 1 Dose A in Healthy Participants, sponsored by AstraZeneca. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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.
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:
The study will comprise:
Exclusion Criteria:
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose A) in Period 2.
Drug: Elecoglipron Reference Formulation Dose A · Drug: Elecoglipron Test formulation 1 Dose A
Participant will receive a single dose of elecoglipron test formulation 1 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
Drug: Elecoglipron Reference Formulation Dose A · Drug: Elecoglipron Test formulation 1 Dose A
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose B) in Period 2.
Drug: Elecoglipron Reference Formulation Dose B · Drug: Elecoglipron Test formulation 1 Dose B
Participant will receive a single dose of elecoglipron test formulation 1 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
Drug: Elecoglipron Reference Formulation Dose B · Drug: Elecoglipron Test formulation 1 Dose B
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose A) in Period 2.
Drug: Elecoglipron Reference Formulation Dose A · Drug: Elecoglipron Test formulation 2 Dose A
Participant will receive a single dose of elecoglipron test formulation 2 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
Drug: Elecoglipron Reference Formulation Dose A · Drug: Elecoglipron Test formulation 2 Dose A
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose B) in Period 2.
Drug: Elecoglipron Reference Formulation Dose B · Drug: Elecoglipron Test formulation 2 Dose B
Participant will receive a single dose of elecoglipron test formulation 2 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
Drug: Elecoglipron Reference Formulation Dose B · Drug: Elecoglipron Test formulation 2 Dose B
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Maximum observed drug concentration (Cmax)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
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)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: At pre-defined intervals from Day 1 to Day 15
Area under concentration-time curve from time 0 to infinity (AUCinf)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: At pre-defined intervals from Day 1 to Day 15
Time to reach maximum observed concentration (tmax)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: At pre-defined intervals from Day 1 to Day 15
Terminal elimination rate constant (λz)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: At pre-defined intervals from Day 1 to Day 15
Terminal elimination half-life (t1/2λz)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: At pre-defined intervals from Day 1 to Day 15
Apparent total body clearance (CL/F)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: At pre-defined intervals from Day 1 to Day 15
Apparent volume of distribution based on the terminal phase (Vz/F)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
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)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
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)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: At pre-defined intervals from Day 1 to Day 15
Number of participants with adverse events (AEs)
To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: From screening (Day -28) up to follow-up visit (Day 18-Day 22)
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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