Print

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.