A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

Purpose

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.

Condition

  • Healthy Participants

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts 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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Research Site
Glendale, California 91206

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

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.