Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

15 september 2026 uppdaterad av: AstraZeneca

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

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

152

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • Glendale, California, Förenta staterna, 91206
        • Rekrytering
        • Research Site
    • Maryland
      • Brooklyn, Maryland, Förenta staterna, 21225
        • Rekrytering
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally.
Läkemedel: Elecoglipron Test formulation 1 Dose A
Elecoglipron tablets will be administered orally.
Experimentell: 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.
Läkemedel: Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally.
Läkemedel: Elecoglipron Test formulation 1 Dose A
Elecoglipron tablets will be administered orally.
Experimentell: 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.
Läkemedel: Elecoglipron Reference Formulation Dose B
Elecoglipron tablets will be administered orally.
Läkemedel: Elecoglipron Test formulation 1 Dose B
Elecoglipron tablets will be administered orally.
Experimentell: 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.
Läkemedel: Elecoglipron Reference Formulation Dose B
Elecoglipron tablets will be administered orally.
Läkemedel: Elecoglipron Test formulation 1 Dose B
Elecoglipron tablets will be administered orally.
Experimentell: 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.
Läkemedel: Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally.
Läkemedel: Elecoglipron Test formulation 2 Dose A
Elecoglipron tablets will be administered orally.
Experimentell: 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.
Läkemedel: Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally.
Läkemedel: Elecoglipron Test formulation 2 Dose A
Elecoglipron tablets will be administered orally.
Experimentell: 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.
Läkemedel: Elecoglipron Reference Formulation Dose B
Elecoglipron tablets will be administered orally.
Läkemedel: Elecoglipron Test formulation 2 Dose B
Elecoglipron tablets will be administered orally.
Experimentell: 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.
Läkemedel: Elecoglipron Reference Formulation Dose B
Elecoglipron tablets will be administered orally.
Läkemedel: Elecoglipron Test formulation 2 Dose B
Elecoglipron tablets will be administered orally.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum observed drug concentration (Cmax)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Area under concentration-time curve from time 0 to infinity (AUCinf)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Time to reach maximum observed concentration (tmax)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Terminal elimination rate constant (λz)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Terminal elimination half-life (t1/2λz)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Apparent total body clearance (CL/F)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Apparent volume of distribution based on the terminal phase (Vz/F)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)
Tidsram: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants with adverse events (AEs)
Tidsram: From screening (Day -28) up to follow-up visit (Day 18-Day 22)
To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants.
From screening (Day -28) up to follow-up visit (Day 18-Day 22)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 juli 2026

Primärt slutförande (Beräknad)

18 november 2026

Avslutad studie (Beräknad)

18 november 2026

Studieregistreringsdatum

Först inskickad

20 juli 2026

Först inskickad som uppfyllde QC-kriterierna

20 juli 2026

Första postat (Faktisk)

23 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D7260C00023

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Kriterier för IPD Sharing Access

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera