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NCT07723833

Overview

NCT ID: NCT07723833
Lead Sponsor: AstraZenecaINDUSTRY
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
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.
Conditions: Healthy Participants
Interventions: Elecoglipron Reference Formulation Dose A
Elecoglipron Test formulation 1 Dose A

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Jul 27, 2026Actual
Primary Completion Date: Nov 18, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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.

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 152Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: AstraZeneca Clinical Study Information CenterContact
information.center@astrazeneca.com

Similar Studies

Participant Group/Arms

Cohort 1-Treatment Sequence AExperimental

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

Cohort 1 - Treatment Sequence BExperimental

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

Cohort 2 - Treatment Sequence CExperimental

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

Cohort 2 - Treatment Sequence DExperimental

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

Cohort 3 - Treatment Sequence EExperimental

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

Cohort 3 - Treatment Sequence FExperimental

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

Cohort 4 - Treatment Sequence GExperimental

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

Cohort 4 - Treatment Sequence HExperimental

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