Study identifier:D7260C00023
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Participants
Phase 1
Yes
Elecoglipron Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A, Elecoglipron Reference Formulation Dose B, Elecoglipron Test formulation 1 Dose B, Elecoglipron Test formulation 2 Dose A, Elecoglipron Test formulation 2 Dose B
All
152
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2026 by AstraZeneca
AstraZeneca
-
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1-Treatment Sequence A 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 Elecoglipron tablets will be administered orally. Drug: Elecoglipron Test formulation 1 Dose A Elecoglipron tablets will be administered orally. |
| Experimental: Cohort 1 - Treatment Sequence B 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 Elecoglipron tablets will be administered orally. Drug: Elecoglipron Test formulation 1 Dose A Elecoglipron tablets will be administered orally. |
| Experimental: Cohort 2 - Treatment Sequence C 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 Elecoglipron tablets will be administered orally. Drug: Elecoglipron Test formulation 1 Dose B Elecoglipron tablets will be administered orally. |
| Experimental: Cohort 2 - Treatment Sequence D 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 Elecoglipron tablets will be administered orally. Drug: Elecoglipron Test formulation 1 Dose B Elecoglipron tablets will be administered orally. |
| Experimental: Cohort 3 - Treatment Sequence E 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 Elecoglipron tablets will be administered orally. Drug: Elecoglipron Test formulation 2 Dose A Elecoglipron tablets will be administered orally. |
| Experimental: Cohort 3 - Treatment Sequence F 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 Elecoglipron tablets will be administered orally. Drug: Elecoglipron Test formulation 2 Dose A Elecoglipron tablets will be administered orally. |
| Experimental: Cohort 4 - Treatment Sequence G 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 Elecoglipron tablets will be administered orally. Drug: Elecoglipron Test formulation 2 Dose B Elecoglipron tablets will be administered orally. |
| Experimental: Cohort 4 - Treatment Sequence H 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 Elecoglipron tablets will be administered orally. Drug: Elecoglipron Test formulation 2 Dose B Elecoglipron tablets will be administered orally. |